Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- BRZSet, Blood Transfusion2Product Code
- BWJLocator, Acupuncture Point2Product Code
- CAKMicrofilter, Blood Transfusion2Product Code
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)2Product Code
- FMFSyringe, Piston2Product Code
- FMGStopcock, I.V. Set2Product Code
- FMINeedle, Hypodermic, Single Lumen2Product Code
- FMSBed, Pediatric Open Hospital2Product Code
- FMTWarmer, Infant Radiant2Product Code
- FMZIncubator, Neonatal2Product Code
- FNGLift, Patient, Ac-Powered2Product Code
- FNJBed, Manual1Product Code
- FNKBed, Hydraulic, Adjustable Hospital1Product Code
- FNLBed, Ac-Powered Adjustable Hospital2Product Code
- FNMMattress, Air Flotation, Alternating Pressure2Product Code
- FNNNipple, Lambs Feeding1Product Code
- FODDevice, Occlusion, Umbilical1Product Code
- FOHMattress, Water, Temperature Regulated1Product Code
- FOKPad, Neonatal Eye1Product Code
- FOSCatheter, Umbilical Artery2Product Code
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2Product Code
- FPASet, Administration, Intravascular2Product Code
- K242692SteadiSet Infusion Set2Cleared 510(K)
- K242763JetCan® Pro Safety Huber Needle2Cleared 510(K)
- K243529Solution Administration Sets2Cleared 510(K)
- K242339Intravascular Extension Sets and Accessories2Cleared 510(K)
- K241058Lyka® PORT Needle Free Access Device (4170Y)2Cleared 510(K)
- K234129Ecomed Disposable Administration Sets2Cleared 510(K)
- K242126I.V. Administration Set2Cleared 510(K)
- K232475Disposable infusion set with needle2Cleared 510(K)
- K222766Disposable Extension Set2Cleared 510(K)
- K232328Insignis™ Syringe Infusion System2Cleared 510(K)
- K231707ResQ Administration Set2Cleared 510(K)
- K230528Extension Set2Cleared 510(K)
- K222780LILY Extension Tube and Needleless Connector2Cleared 510(K)
- K230343ProSeal™ Closed System Administration Set2Cleared 510(K)
- K221327BD Alaris™ Pump Infusion Sets2Cleared 510(K)
- K221411Surflo Winged Infusion Set2Cleared 510(K)
- K221121Volumat Polyethylene I.V. Administration Set2Cleared 510(K)
- K230992DJF Intravascular Administration Set2Cleared 510(K)
- K220301Volumat Line2Cleared 510(K)
- K223645I.V. Administration Set, I.V. Extension Set2Cleared 510(K)
- K223101BD Secondary Infusion Set2Cleared 510(K)
- K220288NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector2Cleared 510(K)
- K220312Polyfusion IV Administration Sets2Cleared 510(K)
- K223088BD SmartSite™ Needle-Free Connector2Cleared 510(K)
- K222889FlowArt® Needle-Free Split Septum Valve2Cleared 510(K)
- K221069Infusion Sets for Single Use with Needles2Cleared 510(K)
- K221075Infusion Sets for Single Use2Cleared 510(K)
- K221078Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use2Cleared 510(K)
- K221518NP Medical nCompass Extension Set with Stabilizing Base2Cleared 510(K)
- K220267AMSafe NeuFlo Needleless Connector2Cleared 510(K)
- K212262PCA Syringe Sets2Cleared 510(K)
- K221473Flowart2Cleared 510(K)
- K221481NeutrArt2Cleared 510(K)
- K213846Q2 Blood Administration Sets2Cleared 510(K)
- K213588Q2 IV Administration Sets2Cleared 510(K)
- K213004Needle Free Connector2Cleared 510(K)
- K202437Infusion Sets for Single Use2Cleared 510(K)
- K213778IV Administration Set2Cleared 510(K)
- K212842Microvolume Luer Access Device2Cleared 510(K)
- K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector2Cleared 510(K)
- K203609Intravascular Administration Sets2Cleared 510(K)
- K202618IV Administration Sets2Cleared 510(K)
- K210381I.V. Administration Set2Cleared 510(K)
- K202279Insignis Subcutaneous Needle Sets2Cleared 510(K)
- K203796Firefly Needleless Connector2Cleared 510(K)
- K210544Medtronic Extended infusion set2Cleared 510(K)
- K210430Intravascular Extension Set2Cleared 510(K)
- K210217Needleless Connector2Cleared 510(K)
- K201626Safety Subcutaneous Infusion Set2Cleared 510(K)
- K200439Velano ExT Extension Set2Cleared 510(K)
- K202672Precision Delivery Infusion Set2Cleared 510(K)
- K201872NeutrArt2Cleared 510(K)
- K200425Female Luer Lock Cap2Cleared 510(K)
- K193088MaxZero Extension Sets with Needle-Free Connector(s)2Cleared 510(K)
- K200661Steripath Micro Blood Collection System2Cleared 510(K)
- K192375Intellifuse Administration and Intellifuse Blood Administration Sets2Cleared 510(K)
- K191640TK Intravascular Administration Set2Cleared 510(K)
- K192681Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)2Cleared 510(K)
- K192366Intravascular Extension Sets and Accessories2Cleared 510(K)
- K191362LifeFlow Blood System2Cleared 510(K)
- K191658IV Sets not made with PVC2Cleared 510(K)
- K190806Flowart2Cleared 510(K)
- K192647neria guard Infusion Set2Cleared 510(K)
- K180739Clearlink System Solution Set2Cleared 510(K)
- K190233K-Shield Advantage Port Access Infusion Set (PAIS)2Cleared 510(K)
- K180843HIgH-Flo Super26 Subcutaneous Needle Sets2Cleared 510(K)
- K182897Velano Vascular Q2 Extension Set2Cleared 510(K)
- K181870Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use2Cleared 510(K)
- K182545Tamper Evident Cap with Male Luer Lock2Cleared 510(K)
- K181718BD FlowSmart Set/MiniMed Pro-Set2Cleared 510(K)
- K173665AMSafe Sure-Lok Needle-Free Connector2Cleared 510(K)
- K173361IV Administration Set2Cleared 510(K)
- K173879MiniMed Mio Advance infusion set2Cleared 510(K)
- K170595IV Administration Sets2Cleared 510(K)
- K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set2Cleared 510(K)
- K172544IV Fat Emulsion Administration Sets2Cleared 510(K)
- K170002Medline Blood Collection Set2Cleared 510(K)
- K171117Carefusion NeutraClear Needle-free connector (EL-NC1000)2Cleared 510(K)
- K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)2Cleared 510(K)
- K171132Carefusion NeutraClear Needle-free connector2Cleared 510(K)
- K162951TUBETECH IV Administration Set2Cleared 510(K)
- K171957MaxZero Extension Sets with Needless Connector2Cleared 510(K)
- K161808Solution Set with 1.2 Micron Air Eliminating Filter2Cleared 510(K)
- K162826Encore Neutral2Cleared 510(K)
- K171101Closed Male Luer2Cleared 510(K)
- K162601Infusion Set for Single Use2Cleared 510(K)
- K163160Sterile Single-use Infusion Set2Cleared 510(K)
- K162804Q2 Low Pressure Power Injection Extension Set2Cleared 510(K)
- K161898Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set2Cleared 510(K)
- K161036Hospira Extension Set, Hospira Primary Set2Cleared 510(K)
- K160007Paclitaxel Sets2Cleared 510(K)
- K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets2Cleared 510(K)
- K161323Solution Set for Epidural Use2Cleared 510(K)
- K153731LifeFlow Rapid Infusion Device (LifeFlow Device)2Cleared 510(K)
- K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set2Cleared 510(K)
- K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®2Cleared 510(K)
- K151250Smart Set2Cleared 510(K)
- K160870Hospira Administration Sets2Cleared 510(K)
- K150921Orbit Infusion Set2Cleared 510(K)
- K160651BD FlowSmart Set, MiniMed Pro-Set2Cleared 510(K)
- K153293Extension Set2Cleared 510(K)
- K151969Hospira Extension Sets2Cleared 510(K)
- K153158Solution Administration Sets with 0.2 Micron Filter2Cleared 510(K)
- K152323Disposable Infusion Needle, Safelock Disposable Infusion Needle2Cleared 510(K)
- K153257BD FlowSmart Set, MiniMed Pro-Set2Cleared 510(K)
- K151991Safelock Disposable Blood Collection Set, Disposable Blood Collection Set2Cleared 510(K)
- K151079Q2 Intravenous Adminstration Sets and Extension Sets2Cleared 510(K)
- K151151U & U Intravascular Administration Set2Cleared 510(K)
- K143446Accu-Chek FlexLink Plus infusion set2Cleared 510(K)
- K143082IV Administration Sets with 200(micro)m Blood Filter2Cleared 510(K)
- K150513Imed Technology Intravascular Administration Set, Imed Technology Extension Set2Cleared 510(K)
- K150059BD FlowSmart Set2Cleared 510(K)
- K150860Nitroglycerin Sets with DUO-VENT Spike2Cleared 510(K)
- K143087Hospira Blood Set2Cleared 510(K)
- K143015Hospira Primary Sets2Cleared 510(K)
- K141285BUSSE EXTENSION SET2Cleared 510(K)
- K142590All Safe Huber Safety Infusion Set2Cleared 510(K)
- K142622IV Administration2Cleared 510(K)
- K142974Extension Sets2Cleared 510(K)
- K142433Hospira Extension Set2Cleared 510(K)
- K140838IV ADMINISTRATION SET WITH HAND PUMP2Cleared 510(K)
- K142367Hospira Primary Sets2Cleared 510(K)
- K143234MaxZero Administration Sets2Cleared 510(K)
- K141200PADI-LOCK2Cleared 510(K)
- K142527Extension Set with BD Q-Syte Luer Access Split Septum2Cleared 510(K)
- K142097SELEC-3 I.V.ADMINISTRATION SET2Cleared 510(K)
- K142036INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS2Cleared 510(K)
- K142011SOLUTION SET/EXTENSION SET2Cleared 510(K)
- K141834SAPPHIRE ADMINISTRATION SET2Cleared 510(K)
- K140175INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K141306TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE2Cleared 510(K)
- K133351NEXUS NIS-6P LUER ACTIVATED DEVICE2Cleared 510(K)
- K140133INFUSET FLOW CONTROL EXTENSION SET2Cleared 510(K)
- K140311CARESITE LUER ACCESS DEVICE2Cleared 510(K)
- K140831MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR2Cleared 510(K)
- K140131SUB-Q SUBCUTANEOUS TISSUE INFUSION SET2Cleared 510(K)
- K133073CAIR DRIVE, NEUTRACLEAR2Cleared 510(K)
- K133894SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)2Cleared 510(K)
- K133867SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)2Cleared 510(K)
- K132841ZYNO MEDICAL ADMINISTRATION SET2Cleared 510(K)
- K132880MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE2Cleared 510(K)
- K132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS2Cleared 510(K)
- K132142NERIA SOFT 90 INFUSION SET2Cleared 510(K)
- K132413MZ10002Cleared 510(K)
- K130879NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS2Cleared 510(K)
- K130416NEXUS TKO-6P LUER ACTIVATED DEVICE2Cleared 510(K)
- K122404MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-262Cleared 510(K)
- K130023K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR2Cleared 510(K)
- K130468ORBIT INFUSION SET2Cleared 510(K)
- K123344K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)2Cleared 510(K)
- K121511MACLIN POWER INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K121269TBA2Cleared 510(K)
- K123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S2Cleared 510(K)
- K123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET2Cleared 510(K)
- K123729VERSARATE FLOW RATE CONTROLER2Cleared 510(K)
- K121803INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K122686ACCU-CHEK ULTRAFLEX INFUSION SET2Cleared 510(K)
- K113471NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET2Cleared 510(K)
- K113470NIPRO SAFE TOUCH HUBER INFUSION SET2Cleared 510(K)
- K112204KDL DISPOSABLE INFUSION SET2Cleared 510(K)
- K120685ZYNO MEDICAL ADMINISTRATION SET2Cleared 510(K)
- K120195SAFETY SUBCUTANEOUS TISSUE INFUSION SET2Cleared 510(K)
- K121634INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR2Cleared 510(K)
- K121092FLOWEASE [SUBCUTANEOUS] INFUSION SET2Cleared 510(K)
- K120375MED-RX PATIENT DELIVERY SET2Cleared 510(K)
- K121032PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP2Cleared 510(K)
- K121554Q-FLO CLOSED MALE LUER CONNECTOR2Cleared 510(K)
- K120395NERIA MULTI SUBCUTANEOUS INFUSION SET2Cleared 510(K)
- K120443NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE2Cleared 510(K)
- K120548HLIC NEEDLE-LESS VALVE2Cleared 510(K)
- K120261PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER2Cleared 510(K)
- K120872ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS2Cleared 510(K)
- K113398NEXUS TKO-6, LUER-ACTIVATED DEVICE2Cleared 510(K)
- K112073INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...2Cleared 510(K)
- K120799ARISURE NEUTRAL VALVE2Cleared 510(K)
- K113683LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL2Cleared 510(K)
- K112799MED-RX EXTENSION SET WITH T-CONNECTOR2Cleared 510(K)
- K112636CYTOGUARD(TM) CLOSED LUER CONNECTOR2Cleared 510(K)
- K112512VANISHPOINT BLOOD COLLECTION SET2Cleared 510(K)
- K112893CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS2Cleared 510(K)
- K111351TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET2Cleared 510(K)
- K102405INFUSION SET FOR POWERPICC SOLO 2 CATHETER2Cleared 510(K)
- K103562CENTURION PRESSURE INJECTABLE EXTENSION SET2Cleared 510(K)
- K111016SAFEPORT MANIFOLD (TM) (OR STOPCOCK)2Cleared 510(K)
- K102512RMS SUBCUTANEOUS NEEDLE SET2Cleared 510(K)
- K110282LIGHTY DD INFUSION SET2Cleared 510(K)
- K103551INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,2Cleared 510(K)
- K103224HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING2Cleared 510(K)
- K100576HIGH PRESSURE SETS-400 PSI2Cleared 510(K)
- K103344INFUSION SETS2Cleared 510(K)
- K101368D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES2Cleared 510(K)
- K100720K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING2Cleared 510(K)
- K103165BLOOD SAMPLING SET2Cleared 510(K)
- K102073MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS2Cleared 510(K)
- K102890K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)2Cleared 510(K)
- K101958AMSINO I.V. ADMINISTRATION AND EXTENSION SETS2Cleared 510(K)
- K101196ACCU-CHEK ULTRFLEX INFUSION SET2Cleared 510(K)
- K101677HOSPIRA INFUSION BLOOD SETS2Cleared 510(K)
- K101180GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,2Cleared 510(K)
- K100946INTRAVSCULAR ADMINISTRATION SET2Cleared 510(K)
- K093489IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY2Cleared 510(K)
- K100434CLAVE NEUTRON2Cleared 510(K)
- K100432POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS2Cleared 510(K)
- K101385DUAL LUER LOCK CAP, MODEL 2C62502Cleared 510(K)
- K092382NEXUS PRESSURE RATED EXTENSION SETS2Cleared 510(K)
- K093773AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS2Cleared 510(K)
- K092930NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED2Cleared 510(K)
- K092905AUTOSTART BURETTE2Cleared 510(K)
- K092527NEXUS INJECTION SITE, MODEL NIS-82Cleared 510(K)
- K093271EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD2Cleared 510(K)
- K092172EXEL I.V. EXTENSION SET2Cleared 510(K)
- K090459DISPOSABLE TPE INFUSION SET2Cleared 510(K)
- K090012DISPOSABLE INFUSION SET2Cleared 510(K)
- K083687BAIXIN INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K083723A6 LUER ACCESS DEVICE2Cleared 510(K)
- K090809MPS ACACIA POWER INJECTABLE INFUSION SET2Cleared 510(K)
- K090134INTRAVENOUS POWER INJECTOR EXTENSION SET2Cleared 510(K)
- K090189ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE2Cleared 510(K)
- K082806SPINNING SPIROS, MODEL CH-20002Cleared 510(K)
- K083482COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET2Cleared 510(K)
- K082027FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 601602Cleared 510(K)
- K083765MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL2Cleared 510(K)
- K083576MISER CONTRAST MANAGEMENT SYSTEM2Cleared 510(K)
- K082818SUBCUTANEOUS NEEDLE INFUSION SET2Cleared 510(K)
- K083472MEDEGEN PRESSURE RATED EXTENSION SETS2Cleared 510(K)
- K081123NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS2Cleared 510(K)
- K081210NIPRO SAFETOUCH HUBER INFUSTION SET2Cleared 510(K)
- K082306POWERLOC CLEAR SAFETY INFUSION SET2Cleared 510(K)
- K081361CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX2Cleared 510(K)
- K073444TRITON MEIDCAL TMED IV-SET2Cleared 510(K)
- K080544UNASSIGNED2Cleared 510(K)
- K073396ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG2Cleared 510(K)
- K080303EZ REGULAR2Cleared 510(K)
- K081289V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE2Cleared 510(K)
- K081156CADD MEDICATION CASSETTE RESERVOIR2Cleared 510(K)
- K080695MOBILE I.V. SYSTEMS 10,20,602Cleared 510(K)
- K080660IV ADMINISTRATION SET2Cleared 510(K)
- K080665NOVOLET2Cleared 510(K)
- K073050SAFESTEP MAX POWER-INJECTABLE INFUSION SET2Cleared 510(K)
- K072375SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET2Cleared 510(K)
- K072894SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)2Cleared 510(K)
- K072576CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED2Cleared 510(K)
- K063631POLYPERF / POLYPERF SAFE2Cleared 510(K)
- K071421PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET2Cleared 510(K)
- K072542MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR2Cleared 510(K)
- K070630HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE2Cleared 510(K)
- K071846MODIFICATION TO EZ HUBER SAFETY INFUSION SET2Cleared 510(K)
- K070547SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)2Cleared 510(K)
- K070801IMM HYPODERMIC NEEDLE SET2Cleared 510(K)
- K070362SURFLO WINGED INFUSION SET2Cleared 510(K)
- K070430PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS2Cleared 510(K)
- K070532SPIROS2Cleared 510(K)
- K062308LMT-KATH-S; LMT-KATH-I2Cleared 510(K)
- K062909REPEATER PUMP II TUBE SETS2Cleared 510(K)
- K070189ACCU-CHEK ULTRAFLEX INFUSION SET2Cleared 510(K)
- K061374INTUITION INFUSION SETS2Cleared 510(K)
- K061285SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS2Cleared 510(K)
- K061771EZ-CONNECT2Cleared 510(K)
- K061115SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 112162Cleared 510(K)
- K060488DERMATECH IV HOLDER2Cleared 510(K)
- K060580K-SHIELD PORT ACCESS INFUSION SET2Cleared 510(K)
- K060352HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS2Cleared 510(K)
- K060672ONE STICK Y EXTENSION SET AND VOLUMETER2Cleared 510(K)
- K060082TIANJIN MEDIS DISPOSABLE INFUSION SET2Cleared 510(K)
- K060074INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N33262Cleared 510(K)
- K053049ALARIS SAFETY MALE LUER2Cleared 510(K)
- K053106TEGO, MODEL D10002Cleared 510(K)
- K053129NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-52Cleared 510(K)
- K052887SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS2Cleared 510(K)
- K052432MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L22Cleared 510(K)
- K052252CONTRAST MEDIA TRANSFER SETS2Cleared 510(K)
- K052722LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS2Cleared 510(K)
- K052658SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K051943SUREFLOW SAFETY INFUSION DEVICE2Cleared 510(K)
- K051264COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS2Cleared 510(K)
- K050906VITALCARE I.V. ADMINISTRATION SET2Cleared 510(K)
- K051437CML 10002Cleared 510(K)
- K051939MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR2Cleared 510(K)
- K051142ANGIODYNAMICS TUMESCENT INFUSION DEVICE2Cleared 510(K)
- K051009HUBER CLEAR SAFETY INFUSION SET2Cleared 510(K)
- K051499INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET2Cleared 510(K)
- K050600MINILOC SAFETY INFUSION SET2Cleared 510(K)
- K043328MICROFLO-SAFE SCALP VEIN SET2Cleared 510(K)
- K041495PENTADEFLUE IV SOLUTION ADMINISTRATION SETS2Cleared 510(K)
- K050207BD POSIFLOW POSITIVE DISPLACEMENT VALVE2Cleared 510(K)
- K043235DRAGON HEART I.V. SET2Cleared 510(K)
- K042129F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK2Cleared 510(K)
- K042666LUTH-ALL SUB-Q NEEDLE SET2Cleared 510(K)
- K042936SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE2Cleared 510(K)
- K041861NEXUS INTRAVENOUS TUBING SETS (NIVTS)2Cleared 510(K)
- K041490IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING2Cleared 510(K)
- K042693IV ADMINISTRATION SET B400 SP2Cleared 510(K)
- K042172CLEO 90 INFUSION SET2Cleared 510(K)
- K041919PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 484516062Cleared 510(K)
- K040533EZ HUBER SAFETY INFUSION SET2Cleared 510(K)
- K042234MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET2Cleared 510(K)
- K041844ALL SAFE HUBER SAFETY INFUSION SETS2Cleared 510(K)
- K042182Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-34322Cleared 510(K)
- K041845NEXUS PAV LUER LOCK DEVICE, MODEL NIS-42Cleared 510(K)
- K040710TEGO NEEDLE FREE ACCESS ACCESS DEVICE2Cleared 510(K)
- K041410PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 51182Cleared 510(K)
- K041042SPLIT SEPTUM INJECTION SITES2Cleared 510(K)
- K041545CONTACT DETACH2Cleared 510(K)
- K041179MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR2Cleared 510(K)
- K032767LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES2Cleared 510(K)
- K040636CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET2Cleared 510(K)
- K033290TALON INFUSION SET, MODEL IP XXXX2Cleared 510(K)
- K040385MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 99002Cleared 510(K)
- K040633CLICK-ON2Cleared 510(K)
- K040527LOW PROFILE LUTHER SAFETY HUBER2Cleared 510(K)
- K033208IVY DEVICES INC. IV/MEDICAL LINE STABILIZER2Cleared 510(K)
- K033892ULTRAFLEX INFUSION SET2Cleared 510(K)
- K033301IV ADMINISTRATION AND CONNECT SETS2Cleared 510(K)
- K033515HUBERPRO SAFETY HUBER INFUSION SET2Cleared 510(K)
- K033576LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE2Cleared 510(K)
- K021692CLC2000 CATHETER PATENCY DEVICE2Cleared 510(K)
- K033350BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER2Cleared 510(K)
- K032934MPS ACACIA SAFEGUARD HUBER DEVICE2Cleared 510(K)
- K032485MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 3132Cleared 510(K)
- K032484MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 3102Cleared 510(K)
- K033099ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-1092Cleared 510(K)
- K032854UNOMEDICAL MONICA INFUSION SET2Cleared 510(K)
- K032150SAFETY-MULTIFLY2Cleared 510(K)
- K021471MARQUETTE HUBER TRAP SAFETY INFUSION SET2Cleared 510(K)
- K020424V SET2Cleared 510(K)
- K020419V SET2Cleared 510(K)
- K031917MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S2Cleared 510(K)
- K031923ULTRASITE VALVE2Cleared 510(K)
- K031500EXCEL PRIMARY SOLUTION SET2Cleared 510(K)
- K031783SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 40052Cleared 510(K)
- K023668JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR2Cleared 510(K)
- K031279SURSHIELD SAFETY WINGED BLOOD COLLECTION SET2Cleared 510(K)
- K031266SURSHIELD SAFETY WINGED INFUSION SET2Cleared 510(K)
- K031361CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP2Cleared 510(K)
- K030385IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR2Cleared 510(K)
- K020189EXEL BUTTERFLY SCALP VEIN SET2Cleared 510(K)
- K030149MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L92Cleared 510(K)
- K030467GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET2Cleared 510(K)
- K030246VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 270722Cleared 510(K)
- K023917WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR2Cleared 510(K)
- K030137MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L92Cleared 510(K)
- K024363NEXUS INJECTION SITE (NIS), MODEL NIS-12Cleared 510(K)
- K030002LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.2Cleared 510(K)
- K023769PREPARE ADMINISTRATION SET2Cleared 510(K)
- K023595BURETTE-IN LINE (150 ML)2Cleared 510(K)
- K023469VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,270622Cleared 510(K)
- K020533EXEL VACULET BLOOD COLLECTION SET2Cleared 510(K)
- K023585FLOSTAR NEEDLELESS CONNECTOR, MODEL FS30002Cleared 510(K)
- K021565LUTHER SAFETY HUBER NEEDLE SET2Cleared 510(K)
- K021916HARMAC HUBER NEEDLE SAFETY DEVICE, H29840012Cleared 510(K)
- K021080NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS2Cleared 510(K)
- K021999GRIPPER PLUS NEEDLE2Cleared 510(K)
- K022209ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS2Cleared 510(K)
- K020926EXTENSION SET, MODELS 1911-5122Cleared 510(K)
- K021488SURECAN SAFETY HUBER NEEDLE INFUSION SETS2Cleared 510(K)
- K021480EXTENSION SET LIGHT-SAFE, MODEL BC5652Cleared 510(K)
- K021530SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN2Cleared 510(K)
- K021487SIMPLICITY EASY ACCESS P INFUSION SET2Cleared 510(K)
- K021296SIMPLICITY QD EASY P INFUSION SET2Cleared 510(K)
- K021395MODIFICATION TO 30 EXTENSION SET2Cleared 510(K)
- K021216SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS2Cleared 510(K)
- K020530EVANS SUB-Q, MODEL MC42062Cleared 510(K)
- K021005SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE2Cleared 510(K)
- K013621BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 3851002Cleared 510(K)
- K020990SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN2Cleared 510(K)
- K020912SIMPLICITY EASY SOFT INFUSION SET2Cleared 510(K)
- K020629SIMPLICITY SIMPLEX SOFT INFUSION SET2Cleared 510(K)
- K013871LIFEGUARD SAFETY INFUSION SET2Cleared 510(K)
- K013714CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP2Cleared 510(K)
- K013949UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR2Cleared 510(K)
- K020544WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA2Cleared 510(K)
- K014062SIMPLICITY EASY ACCESS INFUSION SET2Cleared 510(K)
- K014061SIMPLICITY STARPLUS SOFT INFUSION SET2Cleared 510(K)
- K012879EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE2Cleared 510(K)
- K013950VENTED VIAL ACCESS DEVICE2Cleared 510(K)
- K013502SIMPLICITY CLASSIC WING QD INFUSION SET2Cleared 510(K)
- K013394LIFTLOC SAFETY INFUSION SET2Cleared 510(K)
- K012429SURESET INFUSION SET, MODEL 80232Cleared 510(K)
- K013164SURSHIELD SAFETY WINGED BLOOD COLLECTION SET2Cleared 510(K)
- K013104SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE2Cleared 510(K)
- K011405EXEL INJECTION PLUG WITH CAP2Cleared 510(K)
- K012845SIMPLICITY SOFT QD MICRO INFUSION SET2Cleared 510(K)
- K012526BIOTEQUE SCALP VEIN SET2Cleared 510(K)
- K011888PRESSURE ACTIVATED CHECK VALVE2Cleared 510(K)
- K010404EXEL I.V. ADMINISTRATION SET2Cleared 510(K)
- K012754EZ SET INFUSION SET2Cleared 510(K)
- K012330SIMPLICITY EURO QD INFUSION SET2Cleared 510(K)
- K011928HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-052Cleared 510(K)
- K011216PVC FREE INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K003254CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-0012Cleared 510(K)
- K010888SIDEPORT PINCH CLAMP DEVICE2Cleared 510(K)
- K011858INTERLINK THREADED LOCK CANNULA2Cleared 510(K)
- K011187SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS2Cleared 510(K)
- K011336PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK2Cleared 510(K)
- K011193NAC PLUS NEEDLELESS ACCESS CONNECTOR2Cleared 510(K)
- K011071PARADIGM QUICK-SET INFUSION SET2Cleared 510(K)
- K011580SIMPLICITY SOFT QD SILVER INFUSION SET2Cleared 510(K)
- K010279MEDISYSTEMS LUER ACCESS INJECTION SITE2Cleared 510(K)
- K010197EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET2Cleared 510(K)
- K011120GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES2Cleared 510(K)
- K010886SIMPLICITY WING INFUSION SET2Cleared 510(K)
- K011003SAFESTING AND SAFESTING HUB2Cleared 510(K)
- K010788SIMPLICITY SOFT QD EASY INFUSION SET2Cleared 510(K)
- K010676SIMPLICITY WINGED QD INFUSION SET2Cleared 510(K)
- K010647SIMPLICITY INFUSER INFUSION SET2Cleared 510(K)
- K010846SIMPLICITY SILVER SET SOFT INFUSION2Cleared 510(K)
- K000592UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET2Cleared 510(K)
- K010538PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E2Cleared 510(K)
- K010103SURSHIELD WINGED INFUSION SET2Cleared 510(K)
- K010373SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)2Cleared 510(K)
- K002689SWABSITE SWABBABLE VALVE, MODEL 2450002Cleared 510(K)
- K003977DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET2Cleared 510(K)
- K001329INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET2Cleared 510(K)
- K003854INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K003513TAXOL ADMINISTRATION SET2Cleared 510(K)
- K002449BIOTEQ I.V. (INTRAVENOUS) SET2Cleared 510(K)
- K003283SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)2Cleared 510(K)
- K001233ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S2Cleared 510(K)
- K002492SIMPLICITY SOFT INFUSION SET2Cleared 510(K)
- K003225SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE2Cleared 510(K)
- K002471JETCAN HUBER NEEEDLE SET2Cleared 510(K)
- K001599ACTI-FLEX IV ADMINISTRATION SET2Cleared 510(K)
- K001872I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B4112Cleared 510(K)
- K002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 3802Cleared 510(K)
- K001827PARADIGM SOF-SET MICRO QR, MODELS 324 AND 3252Cleared 510(K)
- K001832PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 3182Cleared 510(K)
- K001106MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 10002Cleared 510(K)
- K002006LIFESHIELD ADDITIVE PIERCING PIN2Cleared 510(K)
- K001424KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD2Cleared 510(K)
- K001423KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY2Cleared 510(K)
- K001426KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER2Cleared 510(K)
- K990331SURGEN VALVE2Cleared 510(K)
- K000472POSI-LINK2Cleared 510(K)
- K000942CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-70902Cleared 510(K)
- K001102PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E2Cleared 510(K)
- K994429VENUSA, LTD. EXTENSION SET WITH FILTER2Cleared 510(K)
- K000343NAC Y-ADP2Cleared 510(K)
- K000152KIPPMED I.V. MANIFOLD2Cleared 510(K)
- K992290EXEL INJECTION PLUG WITH CAP2Cleared 510(K)
- K000017PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A14002Cleared 510(K)
- K993848MILLENNIUM HUBER PLUS SAFETY INFUSION SET2Cleared 510(K)
- K993463INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K993187SHELLY PROTECTED AV FISTULA NEEDLE2Cleared 510(K)
- K992999DAISY PROTECTED SCALP VEIN SET2Cleared 510(K)
- K993147DECAP2Cleared 510(K)
- K992266IV ADMINISTRATION SET2Cleared 510(K)
- K992145ECOMED SCALP VEIN SET2Cleared 510(K)
- K992268NAC PRN NEEDLELESS ACCESS CONNECTOR2Cleared 510(K)
- K992072BOLUS ACCESSORY SET2Cleared 510(K)
- K991979SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 3212Cleared 510(K)
- K991112SAGE CONTRAST MANAGEMENT SYSTEM2Cleared 510(K)
- K990777MED-RX EXTENSION SETS2Cleared 510(K)
- K992104PARSET, MODEL A10001E2Cleared 510(K)
- K991985COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K991932INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K984569AB2 MED-FLO SOLUTION SET2Cleared 510(K)
- K984060LUER ACCESS INJECTION SITE2Cleared 510(K)
- K990496ANESFLOW-DUAL DRIP IV INFUSION SET2Cleared 510(K)
- K991759MAERSK MEDICAL CONTOUR INFUSION SET2Cleared 510(K)
- K991653INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM2Cleared 510(K)
- K991513HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO2Cleared 510(K)
- K991599CADD ADMINISTRATION SET2Cleared 510(K)
- K991301CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 12Cleared 510(K)
- K991255CADD-TPN ADMINISTRATION SET, MODEL 21-70712Cleared 510(K)
- K990693FLEXNEEDLE PLUS2Cleared 510(K)
- K990388TUTOPLUS IV ADMINISTRATION SET2Cleared 510(K)
- K982098TUTODROP 1 AND TUTODROP 22Cleared 510(K)
- K990288FREE FLOW SAFETY DEVICE, MODEL MG 2450522Cleared 510(K)
- K984441KVO CHECK VALVE ACCESSORY, MODEL EV-00012Cleared 510(K)
- K984381BURETROL SOLUTION SETS2Cleared 510(K)
- K990083CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER2Cleared 510(K)
- K984638PARAGON BOLUS ACCESSORY SET2Cleared 510(K)
- K984146PARAGON INFUSION2Cleared 510(K)
- K984063PARAGON BASAL/BOLUS ADMINISTRATION SET2Cleared 510(K)
- K983411COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 1052Cleared 510(K)
- K984561SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B2Cleared 510(K)
- K983926MPS GRAVITY FLOW CONTROL SET2Cleared 510(K)
- K983217ROWE DUAL-CHECK VALVE2Cleared 510(K)
- K983073I.V. EXTENSION SET OR I.V. ADMINISTRATION SET2Cleared 510(K)
- K982672COLLEAGUE PUMP SYRINGE ADAPTER SET2Cleared 510(K)
- K982587MPS FIXED FLOW RATE SET2Cleared 510(K)
- K981792SOLUTION ADMINISTRATION SET2Cleared 510(K)
- K981683HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y2Cleared 510(K)
- K982123CONTRAST CONTROL DEVICE2Cleared 510(K)
- K982047MPS HUBER NEEDLE EXTENSION SET2Cleared 510(K)
- K981386MANAN BLUNT NEEDLE2Cleared 510(K)
- K981548NFC NEEDLEFREE CONNECTOR MODEL 699002Cleared 510(K)
- K981547NFC NEEDLEFREE Y-SITE, MODEL 699702Cleared 510(K)
- K981157STABLE FLOW2Cleared 510(K)
- K980994IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES2Cleared 510(K)
- K980992IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES2Cleared 510(K)
- K974571SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE2Cleared 510(K)
- K980583EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE2Cleared 510(K)
- K981318DUAL LUER LOCK CAP2Cleared 510(K)
- K9801276 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT2Cleared 510(K)
- K973916NP MEDICAL CAPLESS LUER ACTIVATED VALVE2Cleared 510(K)
- K974163MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 3162Cleared 510(K)
- K971844MCKINLEY OUTBOUND-2 SYSTEM2Cleared 510(K)
- K974589SMARTVALVE2Cleared 510(K)
- K974145V3 VALVE2Cleared 510(K)
- K974013EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE2Cleared 510(K)
- K972839PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET2Cleared 510(K)
- K972854PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY2Cleared 510(K)
- K963659EXEL I.V. ADMINISTRATION SET2Cleared 510(K)
- K973167POSITIVE PRESSURE CONNECTOR2Cleared 510(K)
- K973107AMSINO I.V. ADMINISTRATION SET2Cleared 510(K)
- K971004MEDCORP FLOW I.V. REGULATOR EXTENSION SET2Cleared 510(K)
- K972712CORE RESISTANT HUBER INFUSION SETS2Cleared 510(K)
- K972957SA-EF MULTI-LUMEN EXTENSION SET2Cleared 510(K)
- K972527PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS2Cleared 510(K)
- K972493NIPRO DISPOSABLE SOLUTION INFUSION SET2Cleared 510(K)
- K971624DYE STOP AND SAVE - QUICKFILL2Cleared 510(K)
- K972663SMART SET2Cleared 510(K)
- K972135MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET2Cleared 510(K)
- K971500ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER2Cleared 510(K)
- K964439NEEDLE-FREE VALVED CONNECTOR AND CAP2Cleared 510(K)
- K971293LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE2Cleared 510(K)
- K970855CLAVE CONNECTOR2Cleared 510(K)
- K965027VENTED I.V. SET2Cleared 510(K)
- K971701CONTINU-FLO SOLUTION SET2Cleared 510(K)
- K964067GORE IRRIGATION SET2Cleared 510(K)
- K971066TAMARYN I.V. FLOW REGULATOR EXTENSION SET2Cleared 510(K)
- K970909SAFE-CONNECT I.V. SET2Cleared 510(K)
- K971266SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 6815182Cleared 510(K)
- K970524SAFE-CONNECT I.V. EXTENSION SET2Cleared 510(K)
- K970485SMARTSITE ACCESS PIN2Cleared 510(K)
- K970255KIPP MED I.V. MANIFOLD2Cleared 510(K)
- K964918NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS2Cleared 510(K)
- K970259E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET2Cleared 510(K)
- K970800MAXCESS NEEDLEFREE - Y- SITE (100713)2Cleared 510(K)
- K970438INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS2Cleared 510(K)
- K970076NIPRO DISPOSABLE SOLUTION INFUSION SET2Cleared 510(K)
- K964844CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS2Cleared 510(K)
- K964876SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET2Cleared 510(K)
- K964968MR EXTENSION SET (001)2Cleared 510(K)
- K964850SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER2Cleared 510(K)
- K963981VYGON BIONECTOR WITH EXTENSION SET2Cleared 510(K)
- K964812NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET2Cleared 510(K)
- K964456POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 3672Cleared 510(K)
- K964455POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 3332Cleared 510(K)
- K964384MODEL D-290P ADMINISTRATION SET2Cleared 510(K)
- K960771SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM2Cleared 510(K)
- K955775SAFECONNECT VALVE (CATALOG NO. XXXX)2Cleared 510(K)
- K963112MMG MULTI LUMON EXTENSION SET2Cleared 510(K)
- K960431PRESSURE STOPCOCK/MANIFOLD2Cleared 510(K)
- K963009DELTEC SUBCUTANEOUS INFUSION SET2Cleared 510(K)
- K962893INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE2Cleared 510(K)
- K961049FLEX NEEDLE2Cleared 510(K)
- K961928BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-1022Cleared 510(K)
- K963070VENIPUNCTURE KIT2Cleared 510(K)
- K962801SAFE MATE I.V. EXTENSION SETS2Cleared 510(K)
- K962802SAFE MATE I.V. FLUID DELIVERY SETS2Cleared 510(K)
- K961794FLUID ADMINISTRATION SET - CONTRAST MANAGER2Cleared 510(K)
- K955821I.V. ADMINISTRATION SETS2Cleared 510(K)
- K960391STRATO/INFUSAID PERIPORT INFUSION SET 41770,417712Cleared 510(K)
- K961495HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE2Cleared 510(K)
- K961225CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET2Cleared 510(K)
- K954283ENERGIZED CONTAINER SYSTEM (MODIFICATION)2Cleared 510(K)
- K961327BEC NEEDLELESS INJECTION SITE2Cleared 510(K)
- K955585V2 INJECTION SITE2Cleared 510(K)
- K961474POLYFIN INFUSION SET MMT-106/MMT-107/MMT-1332Cleared 510(K)
- K955410SNAPDOSE DEVICE2Cleared 510(K)
- K954883FREE FLOW SAFETY DEVICE2Cleared 510(K)
- K960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETS2Cleared 510(K)
- K960661MAXCESS NEEDLE FREE CONNECTOR (8200)2Cleared 510(K)
- K953825ANGIOFLUSH II FLUID MANAGEMENT SYSTEM2Cleared 510(K)
- K954969POLYFIN QR SUBCUTANEOUS INFUSION SET2Cleared 510(K)
- K955732VENTED SOLUTION SET2Cleared 510(K)
- K955709WINGED & SUBCUTANEOUS INFUSION SETS2Cleared 510(K)
- K952852NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET2Cleared 510(K)
- K955783VLV SA.EF INFUSION PORT EXTENSION SETS2Cleared 510(K)
- K954823VENIPUNCTURE KIT2Cleared 510(K)
- K953746ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET2Cleared 510(K)
- K954983EXTENSION SET WITH CHECK VALVE2Cleared 510(K)
- K940832I.V. ADMINISTRATION SET CONNECTING DEVICE2Cleared 510(K)
- K950970INFUSION SET2Cleared 510(K)
- K954870SIMS DELTEC ANTI-SIPHON VALVE2Cleared 510(K)
- K954841MODEL D-285N ADMINISTRATION SET2Cleared 510(K)
- K954813ICU EXTENSION KIT2Cleared 510(K)
- K954123LOW PROFILE SAFSITE Y-SITE2Cleared 510(K)
- K953791VLV SA EF INFUSION PORT2Cleared 510(K)
- K953343NEEDLELESS INJECTION SITE2Cleared 510(K)
- K953584LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG2Cleared 510(K)
- K951665PP-SPF1 / PP-SPF22Cleared 510(K)
- K953474IV START KIT2Cleared 510(K)
- K953225IVAC BALL VALCE ADMIN. SETS2Cleared 510(K)
- K933898HUBER NEEDLE SETS2Cleared 510(K)
- K952160INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)2Cleared 510(K)
- K952976PLASTIC BLUNT CANNULA2Cleared 510(K)
- K952242TRANSFEER SPIKE II2Cleared 510(K)
- K952810DOSI-FLOW, MODELS 20 & 302Cleared 510(K)
- K953231PPMI-(XXX) AND PPMO-(XXX)2Cleared 510(K)
- K950895HARMAC EXTENSION INFUSION SET2Cleared 510(K)
- K950153VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES2Cleared 510(K)
- K952760FIXED FLOW RATE GRAVITY ADMINISTRATION SETS2Cleared 510(K)
- K952664SOLUTION ADMINISTRATION SET2Cleared 510(K)
- K952392MLI SET2Cleared 510(K)
- K952074SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER2Cleared 510(K)
- K950597CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE2Cleared 510(K)
- K951922ADMINISTRATION SETS WITH BALL FLOAT2Cleared 510(K)
- K942988FILTERED EXTENSION SETS2Cleared 510(K)
- K942271LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE2Cleared 510(K)
- K943591VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEM2Cleared 510(K)
- K945298SMARTFLOW I ADMINISTRATION SET2Cleared 510(K)
- K952053E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS2Cleared 510(K)
- K944692C-SERIES HOMEPUMP2Cleared 510(K)
- K943770LOW VOLUME MULTIPORT2Cleared 510(K)
- K943038STATLOCK-IPIDURAL2Cleared 510(K)
- K944824SUREWING2Cleared 510(K)
- K942931STATLOCK SECUREMENT DEVICES2Cleared 510(K)
- K944293SABRATEK SABSIL SETS2Cleared 510(K)
- K950304DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER2Cleared 510(K)
- K950303DESERET(R) I.V. LOOP AND DESERET (R) J LOOP2Cleared 510(K)
- K950302E-Z SET(R) AND MINICATH(R) INFUSION SETS2Cleared 510(K)
- K946082BEECH PRO LOK FIXED2Cleared 510(K)
- K933848PRESPO 7, SELF-SUFFICIENT DRIP DEVICE2Cleared 510(K)
- K942446I.V. ROLLER GUARD CLAMP2Cleared 510(K)
- K944320VENTED/NON-VENTED GEMINI ADMINISTRATION SET2Cleared 510(K)
- K945617PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS2Cleared 510(K)
- K943897NU-SITE2Cleared 510(K)
- K942349MICROBORE EXTENSION SET2Cleared 510(K)
- K940657IV BAG PUMP2Cleared 510(K)
- K941190CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET2Cleared 510(K)
- K944619I.V.I.D. FLUID ADMINISTRATION SET MARKER2Cleared 510(K)
- K935811BOLUS DISPENSER2Cleared 510(K)
- K945070VERSASAE PLASTIC CANNULA- 11 GAUGE2Cleared 510(K)
- K944208IV ADMINISTRATION SET FPA2Cleared 510(K)
- K941244SAFELINE SYSTEM TURN LOCK CANNULA2Cleared 510(K)
- K940319R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE2Cleared 510(K)
- K942046PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE2Cleared 510(K)
- K940697BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK2Cleared 510(K)
- K941453CHECK VALVE SOLUTION SET2Cleared 510(K)
- K924010REDINOV PERFUSION SET2Cleared 510(K)
- K934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS2Cleared 510(K)
- K934513PROVIDER PUMP SET W/INFUSION CARTRIDGE2Cleared 510(K)
- K942181SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-1162Cleared 510(K)
- K941445EXTENSION SET WITH ANTI-SIPHON VALVE2Cleared 510(K)
- K940897IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET2Cleared 510(K)
- K934119ENERGIZED DRUG CONTAINER SYSTEM2Cleared 510(K)
- K925732ISOFLUX IXZ FLOW REGULATOR2Cleared 510(K)
- K925733ISOFLUX IXL FLOW REGULATOR2Cleared 510(K)
- K925731ISOFLUX IXP FLOW REGULATOR2Cleared 510(K)
- K940867CONTROL-A-FLO(TM) REGULATOR2Cleared 510(K)
- K926448I.V. ADMINISTRATION SET2Cleared 510(K)
- K940054MEASURED VOLUME SOLUTION ADMINISTRATION SET2Cleared 510(K)
- K931173PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH2Cleared 510(K)
- K932165INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K940056WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K940053INFUSION ADMINISTRATION SET2Cleared 510(K)
- K933326LIFECARE PLUMSET VENTED SECONDARY I.V. SET2Cleared 510(K)
- K940072I.V. SET (20 DROPS/ML)2Cleared 510(K)
- K940073EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 302Cleared 510(K)
- K940689WALL IV EXTENSION TUBE2Cleared 510(K)
- K931377SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT2Cleared 510(K)
- K940296SAFE CONNECTOR2Cleared 510(K)
- K933390REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG2Cleared 510(K)
- K932856IRRIGATION ACCESS CAP2Cleared 510(K)
- K9356010.22 MICRON FINAL FILTER WITH EXTENSION TUBE2Cleared 510(K)
- K930854SOLUTION SET WITH .2 MICRON FILTER2Cleared 510(K)
- K931550EZ ADMINISTRATION SET2Cleared 510(K)
- K932637SUBCUTANEOUS INFUSION SET2Cleared 510(K)
- K9316593 LEAD CONNECTOR2Cleared 510(K)
- K933852PRO-LOK EXTENSION SET2Cleared 510(K)
- K933749BEECH VERSA LOK2Cleared 510(K)
- K933732BEECH PROLOK2Cleared 510(K)
- K931658IN-LINE BURETTE SET2Cleared 510(K)
- K932638HUBER NEEDLE INFUSION SET2Cleared 510(K)
- K932446INJECTION SITE2Cleared 510(K)
- K931119DURHAM; NON CORING WINGED ADMINISTRATION SET2Cleared 510(K)
- K930974DURHAM; INJECTION SITE EXTENSION SET, LUER LOCK2Cleared 510(K)
- K930927DURHAM;T ADAPTOR EXTENSIONSET W/INJECTION SITE2Cleared 510(K)
- K925418ENERGIZED CONTAINER SYSTEM2Cleared 510(K)
- K912069AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET2Cleared 510(K)
- K930926DURHAM; Y CHECK SET-LUER LOCK W/INJECTION SITE2Cleared 510(K)
- K922115IVAC NEEDLELESS INJECTION VALVE2Cleared 510(K)
- K925645SELEC-32Cleared 510(K)
- K930750DURHAM; ADM. SET-LUER LOCK W/.22 MICRON FILTER2Cleared 510(K)
- K930751DURHAM; EXTENSION TUBE LUER LOCK W/INJECTION SITE2Cleared 510(K)
- K930406DURHAM; MIN BORE LUER LOCK EXTENSION SET2Cleared 510(K)
- K930410DURHAM; LUER LOCK EXTENSION SET2Cleared 510(K)
- K925362SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET2Cleared 510(K)
- K925930MPC-150 MALE TO MALE LUER ADAPTER2Cleared 510(K)
- K925927MPC-1000 INJECTION CAP/PLUG2Cleared 510(K)
- K926119EXEL HUBER INFUSION SET ROTATING WING2Cleared 510(K)
- K925430LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER2Cleared 510(K)
- K925058BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET2Cleared 510(K)
- K930855REPLACEMENT CAP2Cleared 510(K)
- K925228IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL2Cleared 510(K)
- K926184DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT2Cleared 510(K)
- K925219IVION ADMIN SETS W/FLOW CLIPS2Cleared 510(K)
- K931813NEEDLESAFE HANDGUARD2Cleared 510(K)
- K924721BAXTER SOLUTION ADMINISTRATION SETS2Cleared 510(K)
- K921322MORSE ANESTHESIA MANIFOLD2Cleared 510(K)
- K925126INTERLINK(TM) INJECTION SITE2Cleared 510(K)
- K924718SHROUDED NEEDLE DEVICES2Cleared 510(K)
- K923560ACCU-DROP I.V. EXTENSION SET2Cleared 510(K)
- K922637HORIZON PUMP Y-TYPE BLOOD SET2Cleared 510(K)
- K924207AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET2Cleared 510(K)
- K921899INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET2Cleared 510(K)
- K922469PRO-LOK EXTENSION SET(S)2Cleared 510(K)
- K923882IV-TUBE SECURE2Cleared 510(K)
- K921594HAEMOTROL MODEL #HT-SB/6 BURETTE SET2Cleared 510(K)
- K921429SOLUTION ADMINISTRATION SET2Cleared 510(K)
- K904663AUTO SASH (TM)2Cleared 510(K)
- K913982LIFESHIELD ANESTHESIA SET2Cleared 510(K)
- K922558INTERLINK(TM) INJECTION SITE2Cleared 510(K)
- K920537SUBCUTANEOUS INFUSION SET2Cleared 510(K)
- K921674LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE2Cleared 510(K)
- K921576STRATO LIFEPORT LARGE BORE INFUSION SET2Cleared 510(K)
- K915571CLAVE CONNECTOR2Cleared 510(K)
- K921391SOLUTION ADMINISTRATION SET2Cleared 510(K)
- K921860MODIFICATION TO IV SPIKE2Cleared 510(K)
- K915678MERIT ADMINISTRATION SET2Cleared 510(K)
- K921703CONTINU-FLO(R) SOLUTION SET2Cleared 510(K)
- K915828INJECTION SITE WITH LUER LOCK2Cleared 510(K)
- K915109RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET2Cleared 510(K)
- K9206948000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET2Cleared 510(K)
- K9153903 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES2Cleared 510(K)
- K914924CHEMO PRIMING PIN(TM)2Cleared 510(K)
- K913337INJECTION CAP2Cleared 510(K)
- K914113ANGIOGRAPHIC FLUSH SYSTEM2Cleared 510(K)
- K914792PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET2Cleared 510(K)
- K905208MORSE ANESTHESIA2Cleared 510(K)
- K914026ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM2Cleared 510(K)
- K912856MEDE-FLO I.V. EXTENSION SET2Cleared 510(K)
- K914048NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE2Cleared 510(K)
- K913333I.V. PRIMING SET2Cleared 510(K)
- K9140748000 SERIES VOLUMETRIC PUMP SOLUTION SET2Cleared 510(K)
- K913076I.V. INSTANT TIMER2Cleared 510(K)
- K912861FLU ADMIN/WASTE DISP SYS/PROTEC STA/ADMIN/FLUSH-N-2Cleared 510(K)
- K9136273 PORT ADAPTER2Cleared 510(K)
- K913311SAFETY INJECTION PORT, MODIFICATION2Cleared 510(K)
- K912141VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE2Cleared 510(K)
- K911128MEDIZIV INFUSION SET2Cleared 510(K)
- K910159WINGED ADMININ. SET W/NON-CORING NEEDLE2Cleared 510(K)
- K912860INTRAVASCULAR ADMINISTRATION SETS2Cleared 510(K)
- K9118153RD HAND HELPER2Cleared 510(K)
- K911443INSUL-LINE2Cleared 510(K)
- K911868INTERLINK(TM) BLUNT CANNULA, MODIFICATION2Cleared 510(K)
- K911753INTERVASCULAR ADMINSTRATION SET2Cleared 510(K)
- K911931LUER LOCK INJECTION CAP2Cleared 510(K)
- K911136B-D SAFETY-LOK(TM) I.V. NEEDLES2Cleared 510(K)
- K9052194' LOW VOLUME IV EXTENSION SET2Cleared 510(K)
- K9052184 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP2Cleared 510(K)
- K905374IV EXTENSION SETS WITH .22 MICRON FILTER2Cleared 510(K)
- K910142SPARK KIT(R), MODIFICATION2Cleared 510(K)
- K910546PIGGY LOCK NEEDLE HOUSING2Cleared 510(K)
- K910695AUTO SASH (TM)2Cleared 510(K)
- K904886VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS2Cleared 510(K)
- K902858AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET2Cleared 510(K)
- K904685EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)2Cleared 510(K)
- K902810STERILE I.V. START KIT2Cleared 510(K)
- K902109STATLOCK IV CONNECTOR AND ANCHOR SET2Cleared 510(K)
- K901089LOW VOLUME TRIFURCATED IV EXTENSION SET2Cleared 510(K)
- K901088LOW VOLUME BIFURCATED IV EXTENSION SET2Cleared 510(K)
- K900336V SET2Cleared 510(K)
- K904217PRO-LOK (TM) EXTENSION SETS2Cleared 510(K)
- K903809PROTECTED NEEDLE WITH OR WITHOUT IV SET2Cleared 510(K)
- K904013SPIVE NEEDLE SYSTEM, MODIFICATION2Cleared 510(K)
- K902330E-Z FLO + SET2Cleared 510(K)
- K903541SAFETY INJECTION PORT2Cleared 510(K)
- K901949IV SET2Cleared 510(K)
- K896896KAWASUMI SMALL VEIN INFUSION SET2Cleared 510(K)
- K896892KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET2Cleared 510(K)
- K896893KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE2Cleared 510(K)
- K896894KAWASUMI BLOOD ADMINISTRATION SET2Cleared 510(K)
- K896895KAWASUMI I.V. ADMINISTRATION SET2Cleared 510(K)
- K902166WINGED INFUSION SET2Cleared 510(K)
- K895770EXEL HUBER INFUSION SET2Cleared 510(K)
- K901151I.V. ADMINISTRATION SET CONNECTING DEVICE2Cleared 510(K)
- K902196MODIFIED STICK-GARD SAFETY NEEDLE2Cleared 510(K)
- K900353SHIELDED PIGGYBACK IV NEEDLE2Cleared 510(K)
- K901729SAF-T CLIK I.V. IN-LINE CONNECTOR & EXTENSION SET2Cleared 510(K)
- K901081PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY2Cleared 510(K)
- K901046VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR2Cleared 510(K)
- K900909IN-LINE VIAL CONNECTION SITE2Cleared 510(K)
- K900651TS-1800 MEDICATION TRANSFER SPIKE2Cleared 510(K)
- K900187ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)2Cleared 510(K)
- K900188ADVANCE ADMINISTRATION SETS (VARYING LENGTH)2Cleared 510(K)
- K900644I.V. FREEDOM CLIP2Cleared 510(K)
- K900426IV BIFURCATED EXTENSION SET2Cleared 510(K)
- K900427IV TRIFURCATED EXTENSION SET2Cleared 510(K)
- K897065PORT INFUSION SET (PIS) INFUSION SET (IS)2Cleared 510(K)
- K896561EXTENSION SET2Cleared 510(K)
- K896346GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK2Cleared 510(K)
- K896161AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.2Cleared 510(K)
- K895291IV DISPESNSING SPIKE2Cleared 510(K)
- K895290CHEMO-SPIKE RECONSTITUTION DEVICE2Cleared 510(K)
- K893646VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY2Cleared 510(K)
- K896291INJECTION PORT II --- FOR INTERMITTENT INJECTION2Cleared 510(K)
- K895480BLUNT NEEDLE PORT/I.V. PORT2Cleared 510(K)
- K895046REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE2Cleared 510(K)
- K895481SHAMROCK SAFETY WINGED INFUSION SET2Cleared 510(K)
- K895367INTRAVENOUS EXTENSION SET2Cleared 510(K)
- K895109SECONDARY IV SET WITH PROTECTED NEEDLE2Cleared 510(K)
- K891193MEDI-TRACE ACCU-NATE DEVICE2Cleared 510(K)
- K893716VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 80002Cleared 510(K)
- K894787MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT2Cleared 510(K)
- K894842IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM2Cleared 510(K)
- K893909MODIFIED MATERIAL USED IN INFUSION T2Cleared 510(K)
- K893120KIT, INTRAVENOUS EXTENSION TUBING2Cleared 510(K)
- K892429INJECTION PORT FOR---INTERMITTENT INJECTION2Cleared 510(K)
- K892440KENDALL CURITY EXTENSION TUBES2Cleared 510(K)
- K892438KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES2Cleared 510(K)
- K891164SAMUELS - MICRO -SCLER CATHETER2Cleared 510(K)
- K891146TERUMO SURFLO(R) INJECTION PLUG2Cleared 510(K)
- K891063SURFLO(R) WINGED INFUSION SET2Cleared 510(K)
- K890489EXTENSION SET W/FLOW REGULATOR2Cleared 510(K)
- K891226VASCULAR ACCESS PORT CONTINUOUS INFUSION SET2Cleared 510(K)
- K891176INJECTION SITE PLUG (INTRAVASCULAR ADMINISTRATION)2Cleared 510(K)
- K885031LOW ADSORPTION ADMINISTRATION SET2Cleared 510(K)
- K890679SCALP VEIN SET2Cleared 510(K)
- K890176EXTENSION SETS WITH AND WITHOUT FILTERS2Cleared 510(K)
- K891072INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K884511SAFE MULTIPORT INJECTOR2Cleared 510(K)
- K890340INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K884657LILY I.V. SET2Cleared 510(K)
- K884141MONOPLACE HYPERBARIC EXTENSION SET (L 11055)2Cleared 510(K)
- K883986CRIS ADAPTER2Cleared 510(K)
- K885264WINGED INFUSION SET2Cleared 510(K)
- K884102MODIFIED 7 INCH CONTINUOUS INFUSION SETS2Cleared 510(K)
- K885030STANDARD ADMINISTRATION SETS2Cleared 510(K)
- K883764INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K884264HIGH RISK NEEDLE CONNECTOR ASSEMBLY2Cleared 510(K)
- K884053PRN PLUS + INFUSION SET2Cleared 510(K)
- K883318VALLEYLAB I.V. ADMINISTRATION SETS2Cleared 510(K)
- K883612LECTROSPIRAL2Cleared 510(K)
- K883638SAFESITE INJECTION SITE AND BLUNT CANNULA2Cleared 510(K)
- K882347HARMAC EXTENSION INFUSION SET2Cleared 510(K)
- K88250330 IV EXTENSION SET W/TWO MALE LUER LOCKS2Cleared 510(K)
- K881975SET, INTRAVASCULAR2Cleared 510(K)
- K882797LUER-LOK MULTIFLO ADAPTER2Cleared 510(K)
- K882798MULTIFLO ADAPTER2Cleared 510(K)
- K882302IVAC(R) UNVENTED VOL. INFUSION SET MODEL 520802Cleared 510(K)
- K882007EXTENDED LIFE INJECTION SITE2Cleared 510(K)
- K881321BLOOD/SOLUTION SET W/PRESSURE PUMP2Cleared 510(K)
- K881234VENOVALVE(TM)2Cleared 510(K)
- K881052CHECK VALVE2Cleared 510(K)
- K881390NEEDLE SHIELD NEEDLE DISPOSAL UNIT2Cleared 510(K)
- K880928MARQUETTE MEDICAL, INC. IV EXTENSION SETS2Cleared 510(K)
- K874725SITE SOLUTION ADMINISTRATION SET2Cleared 510(K)
- K880482SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH2Cleared 510(K)
- K874307MODEL DMC-75 MINI-CATHETER SET2Cleared 510(K)
- K874581IVAC(R) DUAL RATE ADAPTER - MODEL 700902Cleared 510(K)
- K874133MX710 SERIES VASCULAR ACCESS INFUSION SET2Cleared 510(K)
- K874467SET, ADMINISTRATION INTRAVASCULAR2Cleared 510(K)
- K872953DISPOSABLE I.V. ADMINISTRATION SET2Cleared 510(K)
- K874403A SERIES OF 7 INCH CONTINUOUS INFUSION SETS2Cleared 510(K)
- K873729RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET2Cleared 510(K)
- K873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE2Cleared 510(K)
- K873885PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET2Cleared 510(K)
- K873876PHARMACIA DELTEC BAG SPIKE SET2Cleared 510(K)
- K873042MODEL 1330 EXTENSION SET2Cleared 510(K)
- K871995MICROS(TM)2Cleared 510(K)
- K872945LOOK FLUID DISTRIBUTION SET2Cleared 510(K)
- K872124CHURCHILL ALBUMIN IV ADMINISTRATION SET2Cleared 510(K)
- K872123CHURCHILL TPN ADMINISTRATION SET2Cleared 510(K)
- K872795CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE2Cleared 510(K)
- K870995SCALP VEIN SET2Cleared 510(K)
- K871843TWO FLUID W/CHECK VALVE2Cleared 510(K)
- K870866THE GRIPPER(TM) PORT-A-CATH NEEDLES2Cleared 510(K)
- K871842TWO FLUID I.V. SETS2Cleared 510(K)
- K871841THREE FLUID I.V. SETS2Cleared 510(K)
- K871732CHURCHILL-H VENTED IV SET W/METERING CHAMBERS2Cleared 510(K)
- K871086IV PUMP SET2Cleared 510(K)
- K871753MASTER MEDICAL DEVICE IS I.V. STAT 22Cleared 510(K)
- K870581LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET2Cleared 510(K)
- K870582LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE2Cleared 510(K)
- K870940SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.2Cleared 510(K)
- K870913INJECTION SITE #014456-1202Cleared 510(K)
- K864296S.C.T. MULTI PORT, INJECTION SITE2Cleared 510(K)
- K870188NORFOLK MEDICAL BUTTERFLY INFUSION SET2Cleared 510(K)
- K864453EMERGENCY & MILITARY INFUSION SYSTEM2Cleared 510(K)
- K864405MANAN CONTRAST MEDIA ADMINISTRATION SET2Cleared 510(K)
- K864164CRIS ADAPTED WITH VOLUME LIMITING BAG2Cleared 510(K)
- K863304PRESELECTED FLOW RATE I.V. SET2Cleared 510(K)
- K864338SECONDARY SET LOCK2Cleared 510(K)
- K863814BAG SPIKE EXTENSION SET2Cleared 510(K)
- K862289KOREAN GREEN CROSS SCALP VEIN SET2Cleared 510(K)
- K862491EXEL BUTTERFLY SCALP VEIN SET2Cleared 510(K)
- K860952I.V. SET WITH AND WITHOUT AIR VENT2Cleared 510(K)
- K862653LUER LOCK ADAPTER/NUT2Cleared 510(K)
- K861182TIMELINE VENIPUNCTURE SYSTEM2Cleared 510(K)
- K860609TIMELINE VENIPUNCTURE SYSTEM2Cleared 510(K)
- K861275HIGH FLOW I.V. SET2Cleared 510(K)
- K860616VOLUME CONTROL SET WITH EXTENSION2Cleared 510(K)
- K861518UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F)2Cleared 510(K)
- K861519UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330F)2Cleared 510(K)
- K861520UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205)2Cleared 510(K)
- K861521UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330)2Cleared 510(K)
- K861250MESULIN, INSULIN INFUSION SET2Cleared 510(K)
- K861430CHURCHILL INJECTION SITE2Cleared 510(K)
- K861439CHURCHILL FEMALE LUER LOCK CAP2Cleared 510(K)
- K860157NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K860322CLINISET INFUSION SET2Cleared 510(K)
- K852616MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE2Cleared 510(K)
- K860541SOLUTION ADMINISTRATION SET2Cleared 510(K)
- K860605FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER2Cleared 510(K)
- K854365IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS2Cleared 510(K)
- K860272SOLUTION ADMINISTRATION SETS2Cleared 510(K)
- K854806RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER2Cleared 510(K)
- K854965IN LINE VALVE CATALOG NO. 2000A2Cleared 510(K)
- K860242JMS INFUSION SET2Cleared 510(K)
- K854804MULTIPLE I.V. SETS2Cleared 510(K)
- K860201PARENTERAL ADMINISTRATION SET2Cleared 510(K)
- K854754PATIENTMATE TM2Cleared 510(K)
- K854658CHURCHILL - HBC VENTED BALL CHECK IV SET2Cleared 510(K)
- K854574IVAC CONTROLLED RELEASE INFUSION SYSTEM2Cleared 510(K)
- K854628CHURCHILL-HCM VENTED IV SET2Cleared 510(K)
- K854446TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET2Cleared 510(K)
- K854636CHURCHILL-HE VENTED IV SET2Cleared 510(K)
- K854630CHURCHILL-HS SUSPENDED NON-VENTED IV SET2Cleared 510(K)
- K854627CHURCHILL-HS SUSPENDED VENTED IV SET2Cleared 510(K)
- K854435CHURCHILL-H NON-VENTED IV SET2Cleared 510(K)
- K854437CHURCHILL-H VENTED IV SET2Cleared 510(K)
- K854436CHURCHILL-H SCALP VEIN SET2Cleared 510(K)
- K854346MEDIFLEX DISPOSABLE TUBING CLAMP2Cleared 510(K)
- K852254I.V. STAT MASTER2Cleared 510(K)
- K853019NITROGLYCERIN INFUSION SET2Cleared 510(K)
- K853287HUBOUT2Cleared 510(K)
- K853527JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET2Cleared 510(K)
- K852606FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)2Cleared 510(K)
- K853204CHURCHILL VENTED IV SET2Cleared 510(K)
- K853385I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT2Cleared 510(K)
- K853255OMNIMED I.V. SOLUTION ADMIN. SET2Cleared 510(K)
- K851516CHERMEL SCALP VEIN SET2Cleared 510(K)
- K853387ET - EXTENSION SETS2Cleared 510(K)
- K853327JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION2Cleared 510(K)
- K853086SECONDARY ADMINISTRATION SET2Cleared 510(K)
- K852881VENTED SECONDARY IV ADMINISTRATION SET2Cleared 510(K)
- K853184PIGGYMATE I.V. TUBING LOCK2Cleared 510(K)
- K852989WINGED INFUSION SETS2Cleared 510(K)
- K852361INTRAVENOUS INJECTION SET2Cleared 510(K)
- K852488CONTROLLED RELEASE INFUSION SYSTEM(CRIS)2Cleared 510(K)
- K852259IVENT INTRAVENOUS ADMINSTRATION SET2Cleared 510(K)
- K852106I.V. ADMINISTRATION SET2Cleared 510(K)
- K852140NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)2Cleared 510(K)
- K851336IV/0165 INFUSION SET2Cleared 510(K)
- K850769VIGGO ACCESSORIES FOR I.V. THERAPY2Cleared 510(K)
- K851299CORRECT FLO2Cleared 510(K)
- K850277VIGGO I.V. ACCESSORIES-VIGGO EXTENSION TUBES ETC.2Cleared 510(K)
- K844843IVAC DRUG ADMINISTRATION DEVICE2Cleared 510(K)
- K850506CORRECT FLO INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K850061MICRO VOLUME DOUBLE LINE EXTENSION SET2Cleared 510(K)
- K850533ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM2Cleared 510(K)
- K850339SPECIAL PROCEDURES PACK2Cleared 510(K)
- K850507CRITIKON I.V. ADMINISTRAION SET2Cleared 510(K)
- K850112OMNIMED IV SOLUTION ADMINISTRATION SET2Cleared 510(K)
- K844917TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE2Cleared 510(K)
- K850088ARTERIAL EXTENSION SET2Cleared 510(K)
- K844820FLOW MED SK 140 BURET2Cleared 510(K)
- K844937IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI2Cleared 510(K)
- K843748ANTI-ASPIRATION VALVE2Cleared 510(K)
- K844255GENT-L-KARE STERILE I.V. START KIT2Cleared 510(K)
- K843090UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM2Cleared 510(K)
- K843692FLU VEN I.V. SET 0153-C PERMA-SET2Cleared 510(K)
- K843631MINISET VEIN INFUSION SETS2Cleared 510(K)
- K842984EXTENSION SET W/INJECTION SITE2Cleared 510(K)
- K842351STERILE DESIGN-CUSTOM STERILE IV KIT2Cleared 510(K)
- K843463PROVIDER BAG SPIKE W/12 MICROBORE EXTEN2Cleared 510(K)
- K842678I.V. TRANSFER SPIKE2Cleared 510(K)
- K843185IVAC C80014 Y SOLUTION ADMIN. SET2Cleared 510(K)
- K843054DEKA SOLUTION ADMIN. SET DK 302-A2Cleared 510(K)
- K842858FLUID ADMINISTRATION LINE W/SPIKE 14-9232Cleared 510(K)
- K843249T-TYPE IV EXTENSION SET2Cleared 510(K)
- K842657ACCESS. TO INTERAVACULAR ADMIN. SET2Cleared 510(K)
- K842088FLU MET 22Cleared 510(K)
- K842985T- EXTENSION SET T-04-C2Cleared 510(K)
- K841717INTRAVENOUS INJECTION SET2Cleared 510(K)
- K841562HESUNG BLOOD TRANSFUSION SETS2Cleared 510(K)
- K842143BENT WINGED MINI-VOL INFUSION SET2Cleared 510(K)
- K841564HESUNG SCALP VEIN SET2Cleared 510(K)
- K841563HESUNG'S SOLUTION INFUSION SETS2Cleared 510(K)
- K841772HEPARIN CAP, INJECTION CAP MALE LUER-2Cleared 510(K)
- K841859SECURA SET2Cleared 510(K)
- K841882THREE WAY INFUSION SET2Cleared 510(K)
- K841361SYRINGE ADDITIVE IV ADMIN. SETS2Cleared 510(K)
- K841185PLASTIC, STERILE TUBING CLOSED SET2Cleared 510(K)
- K841186INFUSION SET SCALP VEIN2Cleared 510(K)
- K841106DELTA MULTIPLE NON RETURN CONNECTOR2Cleared 510(K)
- K840443RETROGRADE INFUSION SET 3ML & 6ML-2Cleared 510(K)
- K841027PROVIDER SITE PREP & CHECK STRIP KIT2Cleared 510(K)
- K841028PROVIDER CAP SET2Cleared 510(K)
- K840760HARVARD ANTI-REFLUX Y-SET2Cleared 510(K)
- K841025TOP DISPOSABLE INFUSION SET2Cleared 510(K)
- K840878QUIK LOK2Cleared 510(K)
- K840619I.V. START KIT2Cleared 510(K)
- K840409INFUSION SET-STERILE2Cleared 510(K)
- K840410SOLUTION ADMIN. SET STERILE2Cleared 510(K)
- K840273LOPEZ LOCK2Cleared 510(K)
- K840212CONCENTRATED PLATELET ADMIN. SET2Cleared 510(K)
- K833398MESULIN INSULIN INFUSION SET2Cleared 510(K)
- K834252PBC EXTENSION SET2Cleared 510(K)
- K834254PBC IV SET VENTED2Cleared 510(K)
- K834253PBC IV SET NON-VENTED2Cleared 510(K)
- K840081IV ADMINISTRATION SET2Cleared 510(K)
- K833939NITROGLYCERIN I.V. ADMINISTRATION SET2Cleared 510(K)
- K834289CONTINU-FLO SOLUTION ADMIN. 2C91022Cleared 510(K)
- K834130INTRAVENOUS FILTER SET2Cleared 510(K)
- K834071LYMPHANGIOGRAPHY SET SPECIAL 30G2Cleared 510(K)
- K833949MICRO INFUSION SET2Cleared 510(K)
- K832284SOLUTION ADMIN. SET 2C9096 W/10 PVC2Cleared 510(K)
- K833740VENOSET MULTI-MED PIGGYBACK W/IVEX-22Cleared 510(K)
- K833741VENOSET MULTI MED DUAL RATE PIGGYBACK2Cleared 510(K)
- K833178SOLUTION ADMINISTRATION LINE W/SPIKE2Cleared 510(K)
- K833034UNIVERSAL VENTED & NON/VOLUME INFUS-2Cleared 510(K)
- K833033INFUSION SET-52-05-1 20 DROPS-MI VOL2Cleared 510(K)
- K833030INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K832542I.V. ADMINISTRATION SET2Cleared 510(K)
- K832549SOLUTION ADMIN. LINE W/SPIKE2Cleared 510(K)
- K832622WINGED INFUSION SET2Cleared 510(K)
- K832434HBO-1 PASS-THROUGH/EXTENSION TUBE2Cleared 510(K)
- K832105ADMINISTRATIVE IV SET2Cleared 510(K)
- K832104STERILE DISP. BUTTERFLY INFUSION SET2Cleared 510(K)
- K831445INFUSION SETS #'S 124 & 142 PERSONAL2Cleared 510(K)
- K832329STERILE IV SET 4 SIZES2Cleared 510(K)
- K832123VENIPUNCTURE VALVE2Cleared 510(K)
- K831311SOLUTION ADMIN. SETS W/FLASHBALL2Cleared 510(K)
- K830182CUSTOM IV SET2Cleared 510(K)
- K830453IV ADMINISTRATION SETS - MVP INFUSION2Cleared 510(K)
- K831087MINI-VOL EXTENSION SET2Cleared 510(K)
- K831088MINI-VOL I.V. SET2Cleared 510(K)
- K830755I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-2Cleared 510(K)
- K830891SPECIALTY SET MODEL IV7A012Cleared 510(K)
- K830868COMBISET OR INFUSION SET2Cleared 510(K)
- K830194IDAS INFUSION SET2Cleared 510(K)
- K830654INFUSION PUMP RETROGRADE EXTEN. AS 7152Cleared 510(K)
- K830565SECURA SET SECONDARY ADMIN. SET2Cleared 510(K)
- K830377SECURA SET PRIMARY ADMIN. SET2Cleared 510(K)
- K823845PORT-LOCK2Cleared 510(K)
- K830448SECURA SET VOLUME LIMITING SET2Cleared 510(K)
- K830258CENTAURSET 300 & 300 P.E.D2Cleared 510(K)
- K830152MINILOOP I.V. CONNECTORS & ADAPTOR2Cleared 510(K)
- K830178MINILOOP DISPOS. IV CONNECTORS ADAPT.2Cleared 510(K)
- K823214DOSIMETRIC RELEASE PROGRAM - ADMIN. SET2Cleared 510(K)
- K823346ACCUSET ADMINISTRATION SET2Cleared 510(K)
- K823347MACRODOT ADD-I-MED ADMIN. SET2Cleared 510(K)
- K823027ACCUDOT 380 SECONDARY I.V. SET2Cleared 510(K)
- K822775INFUS. SETS-9120-50 CM & 9121-100 CM,EXT2Cleared 510(K)
- K822848PRIMARY & SECONDARY I.V. TUBING SETS2Cleared 510(K)
- K822836MICROFLEX-VENOFLUX2Cleared 510(K)
- K822408BOSTON INFUSION SETS2Cleared 510(K)
- K822407BOSTON SCALP VEIN INFUSION SETS2Cleared 510(K)
- K822406BOSTON SOLUTION INFUSION SETS2Cleared 510(K)
- K822354DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB2Cleared 510(K)
- K822027I.V. ADMINISTRATION SET2Cleared 510(K)
- K821995SOLUTION ADMINISTRATION SET (W/O NEEDLE)2Cleared 510(K)
- K821750DESERET E-Z SET INFUSION SET2Cleared 510(K)
- K821377AS 700 SERIES INFUSION PUMP ADMIN.2Cleared 510(K)
- K821764DISPOSABLE INTRAVENOUS INJECTION SYSTEM2Cleared 510(K)
- K821624LOW VOLUME INFUSTION SET2Cleared 510(K)
- K821578VENOSET DUAL-RATE PIGGYBACK W/IVEX &2Cleared 510(K)
- K821515VENTED NITROGLYCERIN I.V. SET2Cleared 510(K)
- K821032MODEL SR-1020LF2Cleared 510(K)
- K820747MONOJECT SAF-T-LOCK2Cleared 510(K)
- K820788CLIRANS PRIMING SET2Cleared 510(K)
- K820133MCGAW FAT EMULSION SET2Cleared 510(K)
- K820453THE INT-STOPPER2Cleared 510(K)
- K820278INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K820203FLUID ADMINISTRATIVE SET, AFI2Cleared 510(K)
- K813259IN-STOPPER (INJECTION CAP2Cleared 510(K)
- K813092ACCUPRO I.V. ADMINISTRATION SET2Cleared 510(K)
- K813194AUTO-SYRINGE SUB-CUTEANEOUS SET2Cleared 510(K)
- K813083VENOFIX SCALP VEIN SET2Cleared 510(K)
- K812657INJECTION CAP, LUER LOCK2Cleared 510(K)
- K812688QI 1150-1T INFUSION T2Cleared 510(K)
- K81188530-30-2 700 SYRINGE EXTENSION SET2Cleared 510(K)
- K812231INTRAVENOUS ADMINISTRATION SET2Cleared 510(K)
- K811914FLU VEN I.V. SETS2Cleared 510(K)
- K811837I.V. ADMINISTRATION SET2Cleared 510(K)
- K811078RADIATION STERILIZED ADMIN. SET2Cleared 510(K)
- K811685I.V. ADMINISTRATION SET2Cleared 510(K)
- K811561LO-VOL I.V. SETS2Cleared 510(K)
- K811463AUTO-SYRINGE MICRO VOLUME EXTENSION SET2Cleared 510(K)
- K811107IV SETS2Cleared 510(K)
- K811110MODELS: 52-01-0, 52-01-12Cleared 510(K)
- K811006SOLUTION ADMINISTRATION SET2Cleared 510(K)
- K810239VENTED PRIMARY PIGGYBACK VENOSET DUAL2Cleared 510(K)
- K810317NITROGLYCERINE IV SET2Cleared 510(K)
- K810921MALE LUER LOCK PLUGS2Cleared 510(K)
- K810721PROCESS CHANGE2Cleared 510(K)
- K802170SURU BLOOD COLLECTION SET2Cleared 510(K)
- K802169SURU INFUSION SET TYPE J2Cleared 510(K)
- K810365HAEMONETICS 170 Y INFUSION SET2Cleared 510(K)
- K802329DISPOSABLE CONSTRAST DELIVERY SPIKE KIT2Cleared 510(K)
- K801871PRIMARY SOLUTION ADMIN. SET-#86-01-0 2602Cleared 510(K)
- K801874MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD2Cleared 510(K)
- K801873MODEL 86-21-0 260 SECONDARY MEDICATION2Cleared 510(K)
- K801872MODEL 86-01-1 260 SOLUTION ADMIN. SET2Cleared 510(K)
- K801821FLOW MED 1502Cleared 510(K)
- K801613MODEL 72-81-0 UNVENTED SOLUTION ADM. SET2Cleared 510(K)
- K801540MCGRAW I.V. ADMINISTRATION SET2Cleared 510(K)
- K800878SECONDARY I.V. TUBING SETS2Cleared 510(K)
- K801179FLOW MED 1602Cleared 510(K)
- K800711VOLUMETRIC PUMP CASSETTE W/ATTACHED SET2Cleared 510(K)
- K800637PLASMA PRODUCTS CO., INTRA/ADMIN/SET-2Cleared 510(K)
- K800638PLASMA PRODUCTS CO. NON-VENTED INTRA/SET2Cleared 510(K)
- K801004FLOW MED 1602Cleared 510(K)
- K800600B-D STASET, I.V. FLOW CONTROLLER2Cleared 510(K)
- K800403MCGAW/EPIC I.V. ADMIN. SET2Cleared 510(K)
- K800358Y-TYPE INFUSION SET (2 LEAD)2Cleared 510(K)
- K791496LOW PLASTICIZER ADMINISTRATION SETS2Cleared 510(K)
- K800137PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN2Cleared 510(K)
- K792228VENTED I.V. SET2Cleared 510(K)
- K792560MASTER I.V. DIAL LOCK2Cleared 510(K)
- K792538CONTINU-FLO ADMIN. SET CODE 2C/2002Cleared 510(K)
- K791930IV EXTENSION SET SL2Cleared 510(K)
- K791672ALBUMIN INTRAVENOUS ADMINISTRATION SET2Cleared 510(K)
- K791529INFUSION NEEDLE SET2Cleared 510(K)
- K791173SURFLO INJECTION PLUG2Cleared 510(K)
- K790901I.V. TUBING ORGANIZER2Cleared 510(K)
- K790582INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K790604CUSTOM TUBING SETS2Cleared 510(K)
- K790574EPIC D2152Cleared 510(K)
- K790424FLU-VEN 015102Cleared 510(K)
- K790408T-CONNECTOR2Cleared 510(K)
- K790077BIOSTIL # 38842Cleared 510(K)
- K790062IV ADMINISTRATION SET WITH BACKCHECK2Cleared 510(K)
- K790108FILTERSET 0.22, I.V. PUMP2Cleared 510(K)
- K782134FILTER FOR HYPERALIMENTATION SET2Cleared 510(K)
- K781813SOLUTION ADMINISTRATION, TIP PROTECTOR2Cleared 510(K)
- K781637MODEL IV 1500 STANDARD BURETTE2Cleared 510(K)
- K781812SOLUTION ADMINISTRATION, FLEX VALVE2Cleared 510(K)
- K781744IV SET WITH GRADUATED CHAMBER2Cleared 510(K)
- K781785I.V. SET WITH IN-LINE FILTER2Cleared 510(K)
- K781575DISPOSABLE LYMPHANGIOGRAM SET2Cleared 510(K)
- K781184INFUSION SET, VENOTHIN 192Cleared 510(K)
- K781190INFUSION SET, VENOTHIN 212Cleared 510(K)
- K781188INFUSION SET, VENOTHIN 252Cleared 510(K)
- K781187INFUSION SET W/ INJECTION SITE, 23D-W2Cleared 510(K)
- K781186INFUSION, VENOTHIN 232Cleared 510(K)
- K781185INFUSION SET W/ INJECTION SITE2Cleared 510(K)
- K781189FLU VEN 01512Cleared 510(K)
- K781036AUTO-SYRINGE INFUSION SET2Cleared 510(K)
- K780970BURETTE SET WITH AIR CONTROL LEVER2Cleared 510(K)
- K780656STERILE INFUSION SET TYPE J2Cleared 510(K)
- K780658STERILE BLOOD ADMINISTRATION SET2Cleared 510(K)
- K780657STERILE BLOOD COLLECTION SET2Cleared 510(K)
- K780655STERILE INFUSION SET TYPE S2Cleared 510(K)
- K780559DISPOSABLE INFUSION SET2Cleared 510(K)
- K780551I.V. ADMINISTRATION SET WITH MINI-SPIKE2Cleared 510(K)
- K780481I.V. LEVER CLAMP2Cleared 510(K)
- K780130BURETTE INTRAVENOUS ADMIN. SETS.2Cleared 510(K)
- K771983SCALP VEIN SET2Cleared 510(K)
- K772008SCALP VEIN SETS2Cleared 510(K)
- K772036IN-LINE BURETTE SET2Cleared 510(K)
- K771593I.V. PUMP SET FOR FAT EMULSION2Cleared 510(K)
- K771267INFUSION SET TYPE S2Cleared 510(K)
- K771271SCALP VEIN SET2Cleared 510(K)
- K771270BLOOD ADMINISTRATION TYPE R2Cleared 510(K)
- K771268INFUSION SET TYPE J2Cleared 510(K)
- K771453FLUID HANDLING DEVICE W/INPUT TUBING2Cleared 510(K)
- K771362FLU VEN 01502Cleared 510(K)
- K771339MALE LUER LOCK PLUG2Cleared 510(K)
- K771204SURFLO WINGED INFUSION SET2Cleared 510(K)
- K770743SOLUSET FOR IV FAT EMULSION2Cleared 510(K)
- K770863FLU VEN 01602Cleared 510(K)
- K770763BURETTE SET, 2C01322Cleared 510(K)
- K770744IV SET THAT REVERTS TO KVO RATE2Cleared 510(K)
- K770589FILTER, INTRAVENOUS W/AUTO AIR VENT2Cleared 510(K)
- K770518PIGGYBACK VENOSET W/0.22 FILTER2Cleared 510(K)
- K770171ERIKA I.V. ADMINISTRATION SET2Cleared 510(K)
- K770051VENOSET FOR I.V. FAT EMULSION2Cleared 510(K)
- K761327IV SETS 2000 SERIES (HS-200,2L0,220)2Cleared 510(K)
- K760110FILTER, I.V. (#4700)2Cleared 510(K)
- K760111FILTER, I.V., WITH FLASH BULB (#4701)2Cleared 510(K)
- K760103CAP, INJECTION (#4600)2Cleared 510(K)
- FPBFilter, Infusion Line2Product Code
- FPKTubing, Fluid Delivery2Product Code
- FPLIncubator, Neonatal Transport2Product Code
- FQHLavage, Jet2Product Code
- FQJSupport, Scrotal, Therapeutic1Product Code
- FQKBinder, Perineal1Product Code
- FQLStocking, Medical Support (For General Medical Purposes)1Product Code
- FQMBandage, Elastic1Product Code
- FRFCleaner, Air, Medical Recirculating2Product Code
- FRLFiber, Medical, Absorbent1Product Code
- FRNPump, Infusion2Product Code
- FRPHolder, Infant Position1Product Code
- FRRChamber, Reverse Isolation, Patient Care2Product Code
- FSALift, Patient, Non-Ac-Powered1Product Code
- FSDBinder, Abdominal1Product Code
- HEFBinder, Breast1Product Code
- HFSShield, Nipple1Product Code
- IKYMattress, Flotation Therapy, Non-Powered1Product Code
- KMKDevice, Intravascular Catheter Securement1Product Code
- KMOBinder, Elastic1Product Code
- KPEContainer, I.V.2Product Code
- KYPSnake Bite Suction Kit1Product Code
- KYQKit, Chemical Snake-Bite3Product Code
- KZDInfusor, Pressure, For I.V. Bags1Product Code
- KZEInjector, Fluid, Non-Electrically Powered2Product Code
- LBIUnit, Neonatal Phototherapy2Product Code
- LDRController, Infusion, Intravascular, Electronic2Product Code
- LGMChamber, Patient Isolation2Product Code
- LGNChamber, Patient Transport Isolation2Product Code
- LGZWarmer, Thermal, Infusion Fluid2Product Code
- LHFWarmer, Microwave, Infusion Fluid2Product Code
- LHISet, I.V. Fluid Transfer2Product Code
- LJLDetectors And Removers, Lice, (Including Combs)1Product Code
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2Product Code
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use2Product Code
- LLKLegging, Compression, Non-Inflatable2Product Code
- LZHPump, Infusion, Enteral2Product Code
- MDRBinder, Medical, Therapeutic1Product Code
- MEAPump, Infusion, Pca2Product Code
- MEBPump, Infusion, Elastomeric2Product Code
- MEGSyringe, Antistick2Product Code
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- MRZAccessories, Pump, Infusion2Product Code
- MZRTopical Approximation System1Product Code
- NEPSystem/Device, Pharmacy Compounding2Product Code
- NGTSaline, Vascular Access Flush2Product Code
- NKKNeedle, Hypodermic, Single Lumen, Reprocessed2Product Code
- NKNSyringe, Piston, Reprocessed2Product Code
- NRWStimulator, Intramuscular, Automatic2Product Code
- NSCInjector, Pen2Product Code
- NTCNursing Pad, Hydrogel1Product Code
- NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)1Product Code
- NXHNursing Pad, Cohesive Gel1Product Code
- NZGBassinet, Hospital2Product Code
- NZWHeparin, Vascular Access Flush2Product Code
- NZXWater, Vascular Access Flush2Product Code
- OBKPort, Protector/Cushion2Product Code
- ODIAdministration Set Docking Station2Product Code
- ODYTunneled Catheter Remover2Product Code
- OJAIntravenous Extension Tubing Set2Product Code
- OKCImplanted Subcutaneous Securement Catheter2Product Code
- OKEPort Introducer Kit2Product Code
- OKLIntravascular Administration Set, Automated Air Removal System2Product Code
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position2Product Code
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2Product Code
- ONMRadiant Infant Warmer Cabinet2Product Code
- PUKAdministration Set Securement Device1Product Code
- OPPPump, Infusion, Insulin Bolus2Product Code
- OSIBariatric Bed2Product Code
- OUWInfant Positioner, Rx, Use In Highly Monitored Setting1Product Code
- OWLPeripheral Catheter Insertion Kit2Product Code
- PDHBlanket, Neonatal Phototherapy2Product Code
- PEFHeparin Flush In 0.45% Sodium Chloride2Product Code
- PEZCentral Venous Catheter Dressing Change Kit2Product Code
- PHCInfusion Safety Management Software2Product Code
- PKPImmunoglobulin G (Igg) Infusion System2Product Code
- PMSPeripheral Intravenous (Piv) Infiltration Monitor2Product Code
- PNDMidline Catheter2Product Code
- POQBlood Transfusion Kit2Product Code
- PORParenteral Administration Kit2Product Code
- PQHIodinated Contrast Media Transfer Tubing Set2Product Code
- PQXEpinephrine Syringe2Product Code
- PRNPediatric Position Holder1Product Code
- PTDSubcutaneous Implanted Apheresis Port2Product Code
- PTINon-Coring (Huber) Needle2Product Code
- PUNLice Removal Kit Containing A Solution1Product Code
- PURVacuum Syringe2Product Code
- PVZNon-Stainless Steel Needle2Product Code
- PWHAdministrations Sets With Neuraxial Connectors2Product Code
- PWNBaby Care Kit2Product Code
- PWOBlood Administration Kit2Product Code
- PWQBuret Administration Intravenous Kit2Product Code
- PWRCatheter Repair Kit2Product Code
- PWXInsect Sting Emergency Kit1Product Code
- PWYLumbar Puncture Tray (Adult & Pediatric)2Product Code
- PXBPercutaneous Introducer Kit2Product Code
- PXIThoracentesis Tray2Product Code
- PXJUmbilical Catheter Insertion Tray2Product Code
- PXKVascular Access Port Kit2Product Code
- PXLVenipuncture Kit2Product Code
- PYRNeuraxial Administration Set - Intrathecal Delivery2Product Code
- PZWCatheter Access Cover, Tamper-Resistant2Product Code
- QBLPiston Syringe Lever2Product Code
- QDMMidazolam Syringe2Product Code
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact2Product Code
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled2Product Code
- QLFOn-Body Injector2Product Code
- QLYOphthalmic Syringe2Product Code
- QMTPrep Kit – Vaccine Injection2Product Code
- QNQLow Dead Space Piston Syringe2Product Code
- QNSLow Dead Space Needle, Single Lumen, Hypodermic2Product Code
- QOGInjection Data Capture Device2Product Code
- QOIIntravenous Catheter Force-Activated Separation Device.2Product Code
- QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant Device2Product Code
- QYMOphthalmic Needle2Product Code
- SCLAllergen And Vaccine Delivery Needles2Product Code
- SEFCentral Venous Catheter With Manual Insertion System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ProSeal™ Closed System Administration Set
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K230343
- 510(k) Type
- Traditional
- Applicant
- Epic Medical Pte Ltd
- Country
- Singapore
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/3/2023
- Days to Decision
- 268 days
- Submission Type
- Summary