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
- K243105Ruby Intravascular Catheter2Cleared 510(K)
- K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)2Cleared 510(K)
- K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)2Cleared 510(K)
- K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)2Cleared 510(K)
- K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)2Cleared 510(K)
- K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter2Cleared 510(K)
- K240359PowerGlide Pro™ Midline Catheter2Cleared 510(K)
- K241845Introcan Safety® 2 IV Catheter2Cleared 510(K)
- K233106AccuCath Ace™ Intravascular Catheter2Cleared 510(K)
- K232234Nouvo Safety Set2Cleared 510(K)
- K233529BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector2Cleared 510(K)
- K231239Nexiva™ Closed IV Catheter System with NearPort™ IV Access2Cleared 510(K)
- K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva2Cleared 510(K)
- K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter2Cleared 510(K)
- K231626OSPREY Closed IV Catheter System (OspreyV2)2Cleared 510(K)
- K221827Mais Central Venous Catheter2Cleared 510(K)
- K230616Polyguard and Polyshield Safety IV Catheters2Cleared 510(K)
- K223018OSPREY PERIPHERAL IV Catheter System2Cleared 510(K)
- K223648Cook® Spectrum® 2 MRC Central Venous Catheter2Cleared 510(K)
- K220772HydroMID 4F Single Lumen Midline Catheter2Cleared 510(K)
- K210929MagiCath II2Cleared 510(K)
- K212370Leaderflex Mini and Leaderflex Nano2Cleared 510(K)
- K220756Introcan Safety 2 IV Catheter2Cleared 510(K)
- K220626Introcan Safety IV Catheter2Cleared 510(K)
- K220584BD Cathena Safety IV Catheter2Cleared 510(K)
- K210037Pluski Safe 1 Safety IV Catheter2Cleared 510(K)
- K213664B. Braun Introcan Safety 2 IV Catheter2Cleared 510(K)
- K213085Introcan Safety 3 Closed IV Catheter2Cleared 510(K)
- K202060Disposable IV catheter2Cleared 510(K)
- K200891BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System2Cleared 510(K)
- K203069HydroMID2Cleared 510(K)
- K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter2Cleared 510(K)
- K193158ACENT™ Central Venous Catheter2Cleared 510(K)
- K201717BD Cathena Safety IV Catheter2Cleared 510(K)
- K200373Deltaven Fast Flash Closed I.V. Catheter Systems2Cleared 510(K)
- K193278MedSource CathMED IV Catheter2Cleared 510(K)
- K192230MF SAFECATH2Cleared 510(K)
- K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)2Cleared 510(K)
- K192676Introcan Safety 2 IV Catheter 18-24 gauge2Cleared 510(K)
- K200263Health Line CT Midline Catheter2Cleared 510(K)
- K192493BD Cathena (TM) Safety IV Catheter2Cleared 510(K)
- K192533Health Line CT CVC2Cleared 510(K)
- K190855BD Acute Central Line2Cleared 510(K)
- K190001Supercath 52Cleared 510(K)
- K191232AccuCath Ace Intravascular Catheter2Cleared 510(K)
- K182252Cook Unimpregnated Central Venous Catheter2Cleared 510(K)
- K183399BD Nexiva Closed IV Catheter System2Cleared 510(K)
- K182870Introcan Safety 3 Closed IV Catheter2Cleared 510(K)
- K182538Merit RadialFlo Arterial Catheter2Cleared 510(K)
- K172496SUPERCATH 5 (26G)2Cleared 510(K)
- K171530Deltaven XiV Max, Deltaven XiV Max FF2Cleared 510(K)
- K173354BD Nexiva Diffusics Closed IV Catheter Systems2Cleared 510(K)
- K172506BD Cathena Safety IV Catheter2Cleared 510(K)
- K172204BD Intima II PLUS Closed IV Catheter System2Cleared 510(K)
- K163358Introcan Safety 3 Closed IV Catheter2Cleared 510(K)
- K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector2Cleared 510(K)
- K161681Nipro SafeTouch IV Catheter2Cleared 510(K)
- K170283BD Nexiva Diffusics Closed IV Catheter System2Cleared 510(K)
- K163513Arrow Endurance Extended Dwell Peripheral Catheter System2Cleared 510(K)
- K162894AccuCath Intravascular Catheter2Cleared 510(K)
- K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter2Cleared 510(K)
- K162377PowerGlide Pro Midline Catheter2Cleared 510(K)
- K161866BioFlo Midline Catheter2Cleared 510(K)
- K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems2Cleared 510(K)
- K160592SUPERCATH 62Cleared 510(K)
- K160235ViaValve Safety I.V. Catheter2Cleared 510(K)
- K153280PowerGlide Pro Midline Catheter2Cleared 510(K)
- K16037420G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System2Cleared 510(K)
- K153298AccuCath Intravascular Catheter2Cleared 510(K)
- K152272Arrow Endurance Extended Dwell Peripheral Catheter System2Cleared 510(K)
- K151698BD Angiocath IV Catheter, BD Insyte IV Catheter2Cleared 510(K)
- K150611MedSource ClearSafe Safety IV Catheter2Cleared 510(K)
- K151513Arrow Endurance Extended Dwell Peripheral Catheter System2Cleared 510(K)
- K142797I.V. Catheter2Cleared 510(K)
- K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology2Cleared 510(K)
- K150407BioFlo Midline Catheter2Cleared 510(K)
- K143610BD INTIMA II CLOSED IV CATHETER2Cleared 510(K)
- K142136ACCUCATH MIDLINE CATHETER SYSTEM2Cleared 510(K)
- K140270NEXUS MIDLINE CT CATHETER2Cleared 510(K)
- K141026LEADERFLEX2Cleared 510(K)
- K140504ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM2Cleared 510(K)
- K133280TERUMO SURFLO I.V. CATHETER2Cleared 510(K)
- K141138SURFLASH SAFETY I.V. CATHETER2Cleared 510(K)
- K140419SUPERCATH52Cleared 510(K)
- K140136NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE2Cleared 510(K)
- K131555MEDSOURCE IV SAFETY CATHETER2Cleared 510(K)
- K133856POWERGLIDE MIDLINE CATHETER2Cleared 510(K)
- K132153SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER2Cleared 510(K)
- K130518MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER2Cleared 510(K)
- K121488JMS SAFE WING CATH (SWC)2Cleared 510(K)
- K123734BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM2Cleared 510(K)
- K121007NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 12Cleared 510(K)
- K123267SURFFLASH(R) PLUS SAFETY I.V. CATHETER2Cleared 510(K)
- K122544TERUMO SURFLASH SAFETY I.V. CATHETER2Cleared 510(K)
- K120839NOVACATH SECURE IV CATHETER SYSTEM-18G2Cleared 510(K)
- K111939M/29TM - PRESSURE INJECTABLE2Cleared 510(K)
- K121073POWERGLIDE MIDLINE CATHETER2Cleared 510(K)
- K113622ORION II CT CVC2Cleared 510(K)
- K113565MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN2Cleared 510(K)
- K112290SUPERCATH Z3V2Cleared 510(K)
- K113700VIAVALVE SAFETY IV CATHETER2Cleared 510(K)
- K113429SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER2Cleared 510(K)
- K120337I-PORT ADVANCE INJECTION PORT2Cleared 510(K)
- K112542YOMURA SAFETY I.V. CATHETER2Cleared 510(K)
- K110794AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS2Cleared 510(K)
- K111366BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM2Cleared 510(K)
- K112347RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE2Cleared 510(K)
- K111236INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 12Cleared 510(K)
- K110443BD INSYTE AUTOGUARD BC2Cleared 510(K)
- K102520BD NEXIVA CLOSED IV CATHETER SYSTEM2Cleared 510(K)
- K100775BD INTIMA II CLOSED IV CATHETER2Cleared 510(K)
- K100974SPECTRUM TURBO-JECT PICC SET2Cleared 510(K)
- K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER2Cleared 510(K)
- K093546SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX2Cleared 510(K)
- K091709MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC2Cleared 510(K)
- K092629SNM FIRMGRIP2Cleared 510(K)
- K083429I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT2Cleared 510(K)
- K090973TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)2Cleared 510(K)
- K082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER2Cleared 510(K)
- K081953SUPERCATH 52Cleared 510(K)
- K090502NOVA SAFE SCALP VEIN BLOOD COLLECTION SET2Cleared 510(K)
- K090122NUOVOGUARD2Cleared 510(K)
- K083454NUOVOCATH2Cleared 510(K)
- K081420VANISHPOINT I.V. CATHETER2Cleared 510(K)
- K080793FIRMGRIP2Cleared 510(K)
- K082362SURSHIELD SAFETY I.V. CATHETER2Cleared 510(K)
- K081113COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS2Cleared 510(K)
- K081690SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER2Cleared 510(K)
- K073471VANTAGECATH INTRAVASCULAR CATHETER2Cleared 510(K)
- K073520ANGIOTECH CVC2Cleared 510(K)
- K073241VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM2Cleared 510(K)
- K070705MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.0392Cleared 510(K)
- K072419ADVANTIV SAFETY I.V. CATHETER2Cleared 510(K)
- K071382SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,2Cleared 510(K)
- K071538ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER2Cleared 510(K)
- K070020COMCASET-P SAFETY IV CATHETER2Cleared 510(K)
- K070451ABLE CENTRAL VENOUS CATHETER2Cleared 510(K)
- K063469MEDICAN ALPHA2Cleared 510(K)
- K061250MULTICATH EXPERT2Cleared 510(K)
- K062108COMCASET SAFETY IV CATHETER2Cleared 510(K)
- K060341SHERLOCK TIP LOCATION SYSTEM (TLS)2Cleared 510(K)
- K052564VYGON LEADER-FLEX2Cleared 510(K)
- K052881VYGON LATEX FREE BIONECTOR2Cleared 510(K)
- K060174SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM2Cleared 510(K)
- K042504CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER2Cleared 510(K)
- K053120STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES2Cleared 510(K)
- K051355VANISHPOINT I.V. CATHETER2Cleared 510(K)
- K052389I-PORT2Cleared 510(K)
- K050114SUPERCATH Z3V2Cleared 510(K)
- K043446EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER2Cleared 510(K)
- K042862BD ONECATH2Cleared 510(K)
- K033843SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING2Cleared 510(K)
- K041345PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES2Cleared 510(K)
- K040427FIBREX CATHETER PATENCY DEVICE2Cleared 510(K)
- K032292BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX2Cleared 510(K)
- K032843NEXIVA CLOSED IV CATHETER SYSTEM2Cleared 510(K)
- K032274COOK FIVE LUMEN CENTRAL VENOUS CATHETER2Cleared 510(K)
- K033500BD CAREFLOW CENTRAL VENOUS CATHETER2Cleared 510(K)
- K033853MODIFICATION TO V-CATH POLY PICC2Cleared 510(K)
- K033250EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR2Cleared 510(K)
- K032417HEPARIN LOCK FLUSH SYRINGE2Cleared 510(K)
- K032777MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE2Cleared 510(K)
- K032962AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE2Cleared 510(K)
- K030479JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET2Cleared 510(K)
- K024007SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J2Cleared 510(K)
- K021557SPECTRUM SILICONE CATHETER2Cleared 510(K)
- K023253PEDIATRIC CENTRAL VENOUS CATHETER KIT2Cleared 510(K)
- K030571ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER2Cleared 510(K)
- K021130SPECATH CENTRAL VENOUS CATHETER KITS2Cleared 510(K)
- K022756NIPRO BIO-FLEX CATHETER2Cleared 510(K)
- K022099SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S2Cleared 510(K)
- K020785INTROCAN SAFETY IV CATHETER2Cleared 510(K)
- K013182TRIPLE LUMEN CENTRAL VENOUS CATHETER2Cleared 510(K)
- K021139TRULINE REINFORCED VALVED INFUSION CATHETER2Cleared 510(K)
- K002142SALINE IV FLUSH SYRINGE2Cleared 510(K)
- K011967BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE2Cleared 510(K)
- K013556MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE2Cleared 510(K)
- K013800INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE2Cleared 510(K)
- K013287NIPRO SAFELET CATH2Cleared 510(K)
- K013073INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS2Cleared 510(K)
- K011937TRULINE INFUSION CATHETERS2Cleared 510(K)
- K012128PROTECTIV ACUVANCE IV CATHETER SYSTEM2Cleared 510(K)
- K0119820.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2Cleared 510(K)
- K011860KEYST0NE MEDICAL PICC CATHETER2Cleared 510(K)
- K011297NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET2Cleared 510(K)
- K010406JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G2Cleared 510(K)
- K010410JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G2Cleared 510(K)
- K003187VACUCATH I.V. CATHETER INTRODUCTER2Cleared 510(K)
- K0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2Cleared 510(K)
- K010021MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S2Cleared 510(K)
- K010034DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-2Cleared 510(K)
- K003245HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML2Cleared 510(K)
- K002786BIOSENSORS CENTRAL VENOUS CATHETER KITS2Cleared 510(K)
- K001795THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD2Cleared 510(K)
- K0006320.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE2Cleared 510(K)
- K000997ZORTRAN DETECTOR2Cleared 510(K)
- K001616MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE2Cleared 510(K)
- K002033BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS2Cleared 510(K)
- K992532VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING2Cleared 510(K)
- K993518MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL2Cleared 510(K)
- K000665TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER2Cleared 510(K)
- K992732STERILE WATER & STERILE 0.9% SODIUM CHLORIDE2Cleared 510(K)
- K000235INSYTE CATHETER, INSYTE AUTOGUARD CATHETER2Cleared 510(K)
- K000087MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR2Cleared 510(K)
- K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER2Cleared 510(K)
- K982558BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE2Cleared 510(K)
- K993515MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L2Cleared 510(K)
- K990390HEPARIN IV FLUSH SYRINGE, 10 U/ML \2Cleared 510(K)
- K990308ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML2Cleared 510(K)
- K9845900.9% SODIUM CHLORIDE FLUSH SYRINGE2Cleared 510(K)
- K992198URETHANE PICC LINE MODEL UPICS-2Cleared 510(K)
- K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT2Cleared 510(K)
- K991406TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER2Cleared 510(K)
- K984614NORMAL SALINE FLUSH SYRINGE2Cleared 510(K)
- K984189ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER2Cleared 510(K)
- K984059ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER2Cleared 510(K)
- K984055CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS2Cleared 510(K)
- K982805INTROCAN SAFETY IV CATHETER2Cleared 510(K)
- K970736BRAUN PREFILLED SYRINGE2Cleared 510(K)
- K983916V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)2Cleared 510(K)
- K983409V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 12Cleared 510(K)
- K980566VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER2Cleared 510(K)
- K981905STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 102912Cleared 510(K)
- K974015ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL2Cleared 510(K)
- K973561MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M2Cleared 510(K)
- K981382PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS2Cleared 510(K)
- K981368PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS2Cleared 510(K)
- K980493I.V. CATHETER SYSTEM2Cleared 510(K)
- K974764INTROSYTE CATHETER2Cleared 510(K)
- K974543L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER2Cleared 510(K)
- K971339INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS2Cleared 510(K)
- K971991GESCO PER-Q-CATH MIDLINE CATHETERS2Cleared 510(K)
- K971990GESCO PER-Q-CATH PICC CATHETERS2Cleared 510(K)
- K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS2Cleared 510(K)
- K972262FIRST PICC CATHETER2Cleared 510(K)
- K972263FIRST PICC CATHETER WITH DUAL LUMENS2Cleared 510(K)
- K972264FIRST MIDCATH CATHETER2Cleared 510(K)
- K972254FIRST MIDCATH CATHETER2Cleared 510(K)
- K963196VYGON UMBILICAL CATHETHER INSERTION TRAY2Cleared 510(K)
- K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER2Cleared 510(K)
- K970669AEROQUIP SAFESTART IV CATHETER2Cleared 510(K)
- K970644AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM2Cleared 510(K)
- K960764SAFE-CATH2Cleared 510(K)
- K964966V-CATH2Cleared 510(K)
- K961552CVP POLYURETHANE CATHETER2Cleared 510(K)
- K964050FIRST MIDCATH CATHETER2Cleared 510(K)
- K964049FIRST MIDCATH CATHETER WITH DUAL LUMENS2Cleared 510(K)
- K964048FIRST MIDCATH CATHETER KIT2Cleared 510(K)
- K962226PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM2Cleared 510(K)
- K953252DISPOSABLE SCALP VEIN INFUSION SET2Cleared 510(K)
- K963867NEO-CARE CATHETERIZATION TRAY2Cleared 510(K)
- K962938EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)2Cleared 510(K)
- K953811MEDCOMP P-CATH2Cleared 510(K)
- K9538050.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE2Cleared 510(K)
- K954112VYGON LIFEVAC MID-LINE TRAY2Cleared 510(K)
- K951620MIDMARK MIDLINE CATHETER2Cleared 510(K)
- K960051NIPRO SAFELET CATH2Cleared 510(K)
- K954428SOLOPICC 24 (60CM) 20GA CATHETER2Cleared 510(K)
- K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER2Cleared 510(K)
- K960013MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM2Cleared 510(K)
- K950118ABRM CATHETER2Cleared 510(K)
- K954887STERILE WATER O.9% STERILE SALINE2Cleared 510(K)
- K953335MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER2Cleared 510(K)
- K955053NIPRO SCALP VEIN SET (DISPOSABL PSV SET)2Cleared 510(K)
- K953120VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE2Cleared 510(K)
- K952645VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE2Cleared 510(K)
- K946170COMFORT-Q SUBCUTANEOUS INJECTION SETS2Cleared 510(K)
- K952058STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE2Cleared 510(K)
- K932946WALLACE IV CANNULA2Cleared 510(K)
- K932947WALLACE Y-CAN2Cleared 510(K)
- K952861ANGIOCATH & INSYTE AUTOGUARD CATHETERS2Cleared 510(K)
- K952757ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER2Cleared 510(K)
- K952256PICC LINE KIT2Cleared 510(K)
- K941678BIONECTOR2Cleared 510(K)
- K950284SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR2Cleared 510(K)
- K945053LF CT HIG PRESSURE CATHETERS2Cleared 510(K)
- K950301ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS2Cleared 510(K)
- K944302THE FLEX-SET SUBCUTANEOUS INFUSION SET2Cleared 510(K)
- K945521CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY2Cleared 510(K)
- K944410CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER2Cleared 510(K)
- K944367CATCO POLYURETHANE UMBILICAL VESSEL CATHETER2Cleared 510(K)
- K944368CATCO SILICONE UMBILICAL VESSEL CATHETER2Cleared 510(K)
- K944336CATCO UMBILICAL VESSEL CATHETER2Cleared 510(K)
- K944504CATCO FIRST PICC2Cleared 510(K)
- K950737LANDMARK MIDLINE CATHETER2Cleared 510(K)
- K944968LANDMARK MIDLINE CATHETER2Cleared 510(K)
- K943349MAHURKAR DUAL LUMEN CATHETER2Cleared 510(K)
- K944660ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY2Cleared 510(K)
- K944511ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC)2Cleared 510(K)
- K942045INSYTE INTRODUCER CATHETER2Cleared 510(K)
- K933467PRN ADAPTER2Cleared 510(K)
- K940634MICRO THERAPEUTICS INFUSION CATHETER2Cleared 510(K)
- K935090CUFF-CATH2Cleared 510(K)
- K941417VITAFLON PLUS/VASCULON2Cleared 510(K)
- K943023CVD BULLETT PERIPHERAL INFUSION CATHETER2Cleared 510(K)
- K932789ONE-SITE IV CONNECTOR2Cleared 510(K)
- K940775INJECTION CAP2Cleared 510(K)
- K940441DIAL MEDICAL SUPPLY FISTULA NEEDLE SET2Cleared 510(K)
- K940385NAVIGATOR-MP CATHETER LOCATION INSTRUMENT2Cleared 510(K)
- K930048SAFE-PICC CATHETER2Cleared 510(K)
- K931073CATH-FINDER2Cleared 510(K)
- K926544PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH2Cleared 510(K)
- K931668PICC INSERTION TRAY2Cleared 510(K)
- K931729I.V. START KIT2Cleared 510(K)
- K932071I.V. START KIT2Cleared 510(K)
- K931027BULLETT PERIPHERAL INFUSION CATHETER2Cleared 510(K)
- K926405.9% NORMAL SALINE TUBE/STERILE WATER TUBE2Cleared 510(K)
- K933050CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH2Cleared 510(K)
- K923702INTIMA POINT GUARD INTRAVASCULAR CATHETER2Cleared 510(K)
- K926097CYBILNATE(R) UMBILICAL CATHETER2Cleared 510(K)
- K923323INTERMITTENT INJECTION SITE2Cleared 510(K)
- K924968L-CATH PEEL-AWAY CATHETER SYSTEM2Cleared 510(K)
- K914378PERIPHERAL INTERVENOUS CATHETER2Cleared 510(K)
- K920638BIO-MATE PIC CATHETER2Cleared 510(K)
- K921955QUIK FLOW2Cleared 510(K)
- K915824HOLE PUNCH2Cleared 510(K)
- K914528SAFEDWEL(R) CENTRAL VENOUS CATHETER2Cleared 510(K)
- K921270SAFE-DWELL PLUS CENTRAL VENOUS CATHETER2Cleared 510(K)
- K920828SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT2Cleared 510(K)
- K914180DESERET(R) FLOW RESTRICTION VALVE2Cleared 510(K)
- K920635E-Z SET/MINICATH INFUSION SETS2Cleared 510(K)
- K920128VERSACATH MAINLINE CENTRAL VENOUS CATHETER2Cleared 510(K)
- K920133VERSACATH SELECTALUMEN INNER CATHETER2Cleared 510(K)
- K920028LANDMARK MIDLINE CATHETER2Cleared 510(K)
- K915065I.V.IRRIGATION POLE2Cleared 510(K)
- K912358LANDMARK ADD-A-LUMEN CATHETER KIT2Cleared 510(K)
- K912165LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM2Cleared 510(K)
- K911251FLEX-IV2Cleared 510(K)
- K912158CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY2Cleared 510(K)
- K912563ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE2Cleared 510(K)
- K905415BRAIDED HIGH PRESSURE CATHETER CONNECTOR2Cleared 510(K)
- K910566VERSACATH(TM) MULTILUMEN SYSTEM2Cleared 510(K)
- K910565VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY2Cleared 510(K)
- K910564VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY2Cleared 510(K)
- K910572INJECTION CAPS2Cleared 510(K)
- K910799LANDMARK VENOUS ACCESS DEVICE2Cleared 510(K)
- K904558DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL2Cleared 510(K)
- K905463GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION2Cleared 510(K)
- K905009DIGITCARE I.V. START KIT2Cleared 510(K)
- K904648SAFE SYTE I.V. CATHETER PLACEMENT UNIT2Cleared 510(K)
- K903347SODIUM CHLORIDE SOLUTION2Cleared 510(K)
- K904150CATH-FINDER(TM) CATHETER TRACKING SYSTEM2Cleared 510(K)
- K903545CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS2Cleared 510(K)
- K904121VIALON OBTURATOR2Cleared 510(K)
- K896813MODIFIED INTRAVENOUS CATHETER2Cleared 510(K)
- K904122INSYTE-A ARTERIAL CATHETERIZATION UNIT2Cleared 510(K)
- K903732KENDALL SAFETRAK(TM) HIGH FLOW CATHETER2Cleared 510(K)
- K901701CENTRAL VENOUS ACCESS CATHETER2Cleared 510(K)
- K902527SPLIT-SECOND INTRODUCER2Cleared 510(K)
- K895597VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER2Cleared 510(K)
- K895812SHARGHP INTRAVENOUS CATHETER2Cleared 510(K)
- K901263NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM2Cleared 510(K)
- K900056CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE2Cleared 510(K)
- K901640MULTICATH PLACEMENT KIT2Cleared 510(K)
- K902135PERCUTANEOUS INTRODUCER KIT2Cleared 510(K)
- K900263ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER2Cleared 510(K)
- K895942GESCO DUAL LUMEN PER-Q-CATH-DL2Cleared 510(K)
- K900116DESERET OPTIMA INTRAVASCULAR CATHETER2Cleared 510(K)
- K895734DESERET INTRAVASCULAR CATHETER2Cleared 510(K)
- K895768EXEL SAFELET CATHETER2Cleared 510(K)
- K896774STREAMLINE VASCULAR ACCESS DEVICE2Cleared 510(K)
- K894611CATHETER CARE KITS2Cleared 510(K)
- K895191ANTI-THROMBOGENIC COATING FOR CATHETERS2Cleared 510(K)
- K893546OPTICALLY CLEAR RADIOPAQUE CATHETER2Cleared 510(K)
- K894371NIPRO SAFELET CATH2Cleared 510(K)
- K893965PROLONG INTRAVASCULAR CATHETER2Cleared 510(K)
- K884577PROCEDURE READY TRAYS2Cleared 510(K)
- K893003TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE2Cleared 510(K)
- K891087TERUMO SURFLO(R) I.V. CATHETER2Cleared 510(K)
- K884325SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE2Cleared 510(K)
- K890751ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT2Cleared 510(K)
- K890435VITAACCESS CATHETER INTRODUCER KIT2Cleared 510(K)
- K884806LUMED EXPANDO-CATH, ACTIV2Cleared 510(K)
- K884701CATH-FINDER SYSTEM2Cleared 510(K)
- K883980LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES)2Cleared 510(K)
- K883866NEOSOFT UMBILICAL VESSEL CATHETER2Cleared 510(K)
- K884259MODIFIED LANDMARK VENOUS ACCESS DEVICE2Cleared 510(K)
- K883415VASCULON 2 INTRAVENOUS CANNULA2Cleared 510(K)
- K881767VIGGO INSUFLON2Cleared 510(K)
- K881976CATHETER, INTRAVASCULAR2Cleared 510(K)
- K882242LANDMARK(TM) VENOUS ACCESS DEVICE2Cleared 510(K)
- K881215CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH2Cleared 510(K)
- K881236TORAY ANTHRON P-U CATHETERS2Cleared 510(K)
- K881666HR(TM) INTRAVASCULAR CATHETER2Cleared 510(K)
- K880260SAFECATH2Cleared 510(K)
- K872998VITAACCESS (TM) CATHETER INTRODUCER SYSTEM2Cleared 510(K)
- K875082O.P.C. INTRAVASCULAR CATHETER2Cleared 510(K)
- K875177J&J SCALP VEIN INFUSION SETS2Cleared 510(K)
- K874582DESERET SPLITTABLE CATHETER2Cleared 510(K)
- K873050VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF2Cleared 510(K)
- K872585CHURCHILL-CATH2Cleared 510(K)
- K871546SAFESIDE(TM) LUMED2Cleared 510(K)
- K870403CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE2Cleared 510(K)
- K864949INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER2Cleared 510(K)
- K862153ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE2Cleared 510(K)
- K864038SUPERCATH I.V. CATHETER2Cleared 510(K)
- K861725INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT2Cleared 510(K)
- K862130COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.2Cleared 510(K)
- K862480BT CATH (INTRAVASCULAR CATHETER)2Cleared 510(K)
- K861479CAVAFIX, CENTRAL VENOUS CATHETER KIT2Cleared 510(K)
- K861117ANTHRON CATHETERS & SETS2Cleared 510(K)
- K861510MULTILUMEN VIAPIC CENTRAL LINE CATHETER2Cleared 510(K)
- K860474STREAM LINE* I.V. CATHETER PLACEMENT UNIT2Cleared 510(K)
- K853988FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI2Cleared 510(K)
- K861015ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS2Cleared 510(K)
- K854308POLYCATH-H CATHETER2Cleared 510(K)
- K860256BRAWN AND GROSHONG CATHETERS2Cleared 510(K)
- K860290VIAPIC CENTRAL LINE CATHETER2Cleared 510(K)
- K854566TERUMO SURFLO ETFE I.V. CATHETER2Cleared 510(K)
- K853348L-CATH EXPANDO CATH2Cleared 510(K)
- K853701JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL2Cleared 510(K)
- K851142TELET-LEX MEDICAL IV CATHETER PLACEMENT2Cleared 510(K)
- K851981NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC.2Cleared 510(K)
- K851327DESERET ARTERIAL CATHETER2Cleared 510(K)
- K852078SPECTRUM(TENTATIVE)2Cleared 510(K)
- K844193QUINTON INJECTION SEALING CAP2Cleared 510(K)
- K850887DRESSING CHANGE KIT2Cleared 510(K)
- K851101BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET2Cleared 510(K)
- K850276VIGGO NEOFLON INFUSION CANNULA2Cleared 510(K)
- K850460VIGGO SECALON T CATHETER2Cleared 510(K)
- K850349VIGGO ARTERIAL CANNULA2Cleared 510(K)
- K850278VASCULON I.V. CANNULAE2Cleared 510(K)
- K850398NU-CATH EMERGENCY KIT2Cleared 510(K)
- K842577CATH-TECH POLYURETHANE UMBILICAL VESS2Cleared 510(K)
- K842133EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS2Cleared 510(K)
- K850369QUINTON WHITE SEALING CAP2Cleared 510(K)
- K841880ERYTHROCATH UMBILICAL CATHETER2Cleared 510(K)
- K843033DESERET INTRAVASCULAR CATHETER2Cleared 510(K)
- K844219DESERET DENTRAL LINE CATHETER2Cleared 510(K)
- K844113DESERET SUBCLAVIAN JUGULAR CATHETER SET2Cleared 510(K)
- K840815LUER LOCKING ADAPTER(MATERIAL CHANGE)2Cleared 510(K)
- K840116DESERET INFANT CENTRAL VENOUS CATHE-2Cleared 510(K)
- K840862DESERET CENTRAL VENOUS CATHETER2Cleared 510(K)
- K840355DESERET MULTILUMEN SUBCLAVIAN JUGULAR2Cleared 510(K)
- K840183DESERET MULTILUMEN SUBCLAVIAN JUGULAR2Cleared 510(K)
- K834227DESERET SUBCLAVIAN JUGULAR CATH. SET2Cleared 510(K)
- K834255PBC SCALP VEIN SET2Cleared 510(K)
- K834073CENTRAL VEIN CATHERIZATION TRAY CC-202Cleared 510(K)
- K834393DESERET NEONATAL CATHETER SET2Cleared 510(K)
- K834480INJECTION CAP2Cleared 510(K)
- K833079CENTRACATH #130,135 & 137-HEMOCATH #2Cleared 510(K)
- K833657ANGIO-SET INTRAVENOUS CATH. SET2Cleared 510(K)
- K832558RELEASE OF ETHYLENE OXIDE-STERILIZ. DEV2Cleared 510(K)
- K833135INTRACATH INTRAVENOUS CATHETER UNIT2Cleared 510(K)
- K833092DESERET ANGIO-GUIDE LARGE VEIN CATH.2Cleared 510(K)
- K833091DESERET SUBCLAVIAN JUGULAR CATH-SET2Cleared 510(K)
- K832624TOP VENULA I.V. CATHETER SET2Cleared 510(K)
- K830541INJECTION SEALING CAP 137912Cleared 510(K)
- K830972I.V. CATHETER PLACEMENT UNIT POLYURETH2Cleared 510(K)
- K830765WINGED CATHETER2Cleared 510(K)
- K830573PRE VUE2Cleared 510(K)
- K830539INTRAVASCULAR CATHETER SET2Cleared 510(K)
- K823565MULTI-LUMEN INTRAVENOUS CATHETER2Cleared 510(K)
- K823351CENTRAL VENOUS CATHETER2Cleared 510(K)
- K822776TEFLON CANNULA2Cleared 510(K)
- K823017INTRAVENOUS CATHETER PLACEMENT UNIT &2Cleared 510(K)
- K822023DESERET SUBCLAVIAN JUGULAR CATH. SET2Cleared 510(K)
- K821929SUBCLAVIAN2Cleared 510(K)
- K821679LEONARD/NORTON HYPERALIMENTATION CATHET.2Cleared 510(K)
- K821699DESERET SUBCLAVIAN JUGULAR CATHETER SET2Cleared 510(K)
- K821577DESERET ANGIO GUIDE2Cleared 510(K)
- K821372DESERET INTRACATH INTRAVENOUS CATHETER2Cleared 510(K)
- K821371DESERET SUBCLAVIAN JUGULAR CATHETER SET2Cleared 510(K)
- K813374NUTRICATH2Cleared 510(K)
- K813396VERSCHLUBSTOPFEN COMB-CLOSING STOPPER2Cleared 510(K)
- K813345CRITIKON I.V. CATHETER PLACEMENT UNIT2Cleared 510(K)
- K812137B-D HEPARINIZED LONGDWEL I.V. CATHETER2Cleared 510(K)
- K812159INTRAVASCULAR CATHETER2Cleared 510(K)
- K811171VASCULON II I.V. CATHETER2Cleared 510(K)
- K803238INTRAVASCULAR CATHETER2Cleared 510(K)
- K802918ANTHRON CATHETER SET2Cleared 510(K)
- K801537START IT WITH & WITHOUT I.V. CATH. UNIT2Cleared 510(K)
- K801941BURRON MICROCATH INTRA. CATH. PLACEMENTT2Cleared 510(K)
- K801575L-CATH INTRAVENOUS PLACEMENT UNIT2Cleared 510(K)
- K801414ERYTHROCATH INTRAVENOUS CATHETER PLA. U.2Cleared 510(K)
- K800786INJECTION SITE, CODE NO. 31002Cleared 510(K)
- K800525MEDICAL COMPONENTS IV CATHETER2Cleared 510(K)
- K791918JELCO WINGED INTRAVASCULAR CATHETER2Cleared 510(K)
- K790914SILASTIC INTRAVENOUS CATHETER UNIT2Cleared 510(K)
- K790967CATHETER METAL HUB/RADIOPAQUE2Cleared 510(K)
- K772011WHOLEY OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K790968CATHETER METAL HUB/NONRADIOPAQUE2Cleared 510(K)
- K780350I.V. START KIT2Cleared 510(K)
- K780105NEEDLE CONNECTING SET, BLUNT2Cleared 510(K)
- K772354I.V. CATHETER2Cleared 510(K)
- K771381IV CATHETER HUB2Cleared 510(K)
- K771573DUO-CATH FEMORAL2Cleared 510(K)
- K770751CATHETERS, OVER-THE-NEEDLE2Cleared 510(K)
- K770510CANNULA, INTRAVENOUS, TEFLON2Cleared 510(K)
- K770511CANNULA, INTRAVENOUS, HEPARINIZED2Cleared 510(K)
- K770181I.V. CATHETER PLACEMENT UNIT2Cleared 510(K)
- K770403CATHETER-THRU-NEEDLE DEVICE2Cleared 510(K)
- K760319KIT, CATHETER2Cleared 510(K)
- K760163CATHETER, INTRAVASCULAR (MEDICUT T)2Cleared 510(K)
- FPASet, Administration, Intravascular2Product Code
- 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
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- 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
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- 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
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K231401
- 510(k) Type
- Traditional
- Applicant
- Poly Medicure Limited
- Country
- India
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/21/2023
- Days to Decision
- 129 days
- Submission Type
- Summary