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
- 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
- K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology2Cleared 510(K)
- K252792PM2™ System with ECGuide™ Connector2Cleared 510(K)
- K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr2Cleared 510(K)
- K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)2Cleared 510(K)
- K243484PM2+ System and SmartPICC Stylet2Cleared 510(K)
- K241587pilot TLS2Cleared 510(K)
- K241910Neonav ECG Tip Location System2Cleared 510(K)
- K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)2Cleared 510(K)
- K240486PM2 System and ECGuide Connector2Cleared 510(K)
- K233149CATHTONG III Tapered PICC Catheter2Cleared 510(K)
- K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters2Cleared 510(K)
- K232594CATHTONG™ II PICC Catheter2Cleared 510(K)
- K232571CATHTONG™ II PICC Catheter2Cleared 510(K)
- K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly2Cleared 510(K)
- K220363VPS Rhythm DLX Device with TipTracker Technology2Cleared 510(K)
- K213550HydroPICC 5F Dual Lumen Catheter2Cleared 510(K)
- K210264BD PowerPiCC Catheter2Cleared 510(K)
- K201452Groshong NXT PICC Catheter2Cleared 510(K)
- K200037Piccolo Medical SmartPICC System2Cleared 510(K)
- K192246Biowy PICC Catheter S Kit2Cleared 510(K)
- K193015HydroPICC (PICC-142)2Cleared 510(K)
- K180546Jet Power Injectable PICC2Cleared 510(K)
- K1819045 FR Dual Lumen Piper PICC2Cleared 510(K)
- K180560Sherlock 3CG+ T ip Confirmation System2Cleared 510(K)
- K173956Biowy PlCC Catheter2Cleared 510(K)
- K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology2Cleared 510(K)
- K172511Hickman TriFusion Catheter2Cleared 510(K)
- K180567C3 Wave System2Cleared 510(K)
- K172899Vygon PICCs2Cleared 510(K)
- K171994Silicone Peripherally Inserted Central Venous Catheter Set/Tray2Cleared 510(K)
- K172885HydroPICC2Cleared 510(K)
- K170934C3 Wave System2Cleared 510(K)
- K171931Celerity ECG Cable Accessory Pack2Cleared 510(K)
- K172397Sherlock 3CG Tip Positioning System Stylet2Cleared 510(K)
- K172039CATHTONG II PICC Catheter2Cleared 510(K)
- K170486CATHTONG II PICC Catheter2Cleared 510(K)
- K162441PowerPICC Provena Catheters with SOLO Valve Technology2Cleared 510(K)
- K163452PICC Maximal Barrier Nursing Kit2Cleared 510(K)
- K160925VPS Rhythm Device with TipTracker Technology2Cleared 510(K)
- K162443PowerPICC Provena Catheters2Cleared 510(K)
- K161496Turbo-Flo PICC Sets2Cleared 510(K)
- K161765CG+ Arrow JACC2Cleared 510(K)
- K153469Cathtong I PICC Catheter2Cleared 510(K)
- K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter2Cleared 510(K)
- K152819Amecath Peripheral inserted Central Venous Catheter Sets2Cleared 510(K)
- K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS2Cleared 510(K)
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC2Cleared 510(K)
- K152261PICC Tip Positioning Aid2Cleared 510(K)
- K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC2Cleared 510(K)
- K143238C3 Wave2Cleared 510(K)
- K150527Xcela Power Injectable PICC2Cleared 510(K)
- K150448NMI PICC III and NMI PICC IV2Cleared 510(K)
- K142889Celerity PICC Tip Confirmation System2Cleared 510(K)
- K141634NAUTILUS DELTA2Cleared 510(K)
- K142267Sherlock 3CG Tip Positioning System Stylet2Cleared 510(K)
- K142616PICC Maximal Barrier Nursing Kit2Cleared 510(K)
- K141633PRO-PICC WITH VALVE TECHNOLOGY2Cleared 510(K)
- K141818TURBO-JECT PICC SETS2Cleared 510(K)
- K141151CT MIDLINE2Cleared 510(K)
- K140799CELERITY SYSYEM2Cleared 510(K)
- K140345THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)2Cleared 510(K)
- K140266NMI PICC IV2Cleared 510(K)
- K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET2Cleared 510(K)
- K133264NMI PICC III2Cleared 510(K)
- K132567ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN2Cleared 510(K)
- K130897MEDCOMP VASCU-PICC WITH VALVE2Cleared 510(K)
- K132885TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET2Cleared 510(K)
- K132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET2Cleared 510(K)
- K1316876F X 60CM TRIPLE PRO-LINE CT BASIC IR SET2Cleared 510(K)
- K131942NMI PICC III CATHETER, NMI HPICC III CATHETER2Cleared 510(K)
- K130507FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER2Cleared 510(K)
- K1236173F PRO-PICC2Cleared 510(K)
- K131038NMI PICC MAXIMAL BARRIER NURSING KITS2Cleared 510(K)
- K130876CG+ ARROW PICC POWERED BY ARROW VPS STYLET2Cleared 510(K)
- K130034UNI-PICC2Cleared 510(K)
- K123759CG+ ARROW PICC POWERED BY ARROW VPS STYLET2Cleared 510(K)
- K122423VASU-PICC2Cleared 510(K)
- K121501ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)2Cleared 510(K)
- K113225NYLUS PICC2Cleared 510(K)
- K122882NMI HPICC III2Cleared 510(K)
- K122545CG+ ARROW PICC POWERED BY ARROW VPS STYLET2Cleared 510(K)
- K121941ARROW PICC POWERED BY ARROW VPS STYLET2Cleared 510(K)
- K121089NMI PICC III2Cleared 510(K)
- K121990PICC CONVENIENCE KIT2Cleared 510(K)
- K113277ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS2Cleared 510(K)
- K121094MEDCOMP VASCU-PICC & MIDLINE CATHETERS2Cleared 510(K)
- K112896ARRW EVOLUTION2Cleared 510(K)
- K1209801.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC2Cleared 510(K)
- K1209812.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC2Cleared 510(K)
- K113808THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)2Cleared 510(K)
- K113043DIRECT ANTIBIOTIC INFUSION KIT2Cleared 510(K)
- K112744SAPIENS TIP CONFIRMATION SYSTEM2Cleared 510(K)
- K110914TRIPLE LUMEN PFM PICC2Cleared 510(K)
- K110627NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER2Cleared 510(K)
- K111906XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY2Cleared 510(K)
- K111244TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)2Cleared 510(K)
- K1029662.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC2Cleared 510(K)
- K102159POWERPICC SV CATHETERS2Cleared 510(K)
- K101326NMI IC2Cleared 510(K)
- K100635ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-455042Cleared 510(K)
- K101329SYNERGY CT PICC2Cleared 510(K)
- K093775EVGUIDE TIP LOCATION SYSTEM2Cleared 510(K)
- K092306SECURACATH UNIVERSAL2Cleared 510(K)
- K093406MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 121055192Cleared 510(K)
- K0939276F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER2Cleared 510(K)
- K093252FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER2Cleared 510(K)
- K093366NMI PICC II2Cleared 510(K)
- K093309PRO-LINE CT (BASIC TRAY) MODEL MR280361012Cleared 510(K)
- K092040PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 4301032402Cleared 510(K)
- K091924VPS CATHETER2Cleared 510(K)
- K092347PRO-PICC CT2Cleared 510(K)
- K091953PRO-PICC2Cleared 510(K)
- K091488FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C2Cleared 510(K)
- K091324SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET2Cleared 510(K)
- K091586VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN2Cleared 510(K)
- K091670BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER2Cleared 510(K)
- K0914661.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S502Cleared 510(K)
- K091261NMI PICC2Cleared 510(K)
- K083920FLOWPICC CATHETER2Cleared 510(K)
- K083873PICC (CT RATED AND NON-RATED)2Cleared 510(K)
- K083763ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN2Cleared 510(K)
- K082481FLOWPICC CATHETER2Cleared 510(K)
- K081904PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)2Cleared 510(K)
- K080604PRESSURE INJFECTABLE PICC2Cleared 510(K)
- K073451PRESSURE INJECTABLE PICC2Cleared 510(K)
- K072518CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)2Cleared 510(K)
- K072625TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)2Cleared 510(K)
- K072509PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY2Cleared 510(K)
- K072391PFM PICC2Cleared 510(K)
- K071875V-CATH POLY PICC2Cleared 510(K)
- K072230POWERPICC SOLO2Cleared 510(K)
- K072196ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT2Cleared 510(K)
- K071361R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,0052Cleared 510(K)
- K070002BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER2Cleared 510(K)
- K070613ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT2Cleared 510(K)
- K0709964 FR SINGLE LUMEN (SL) POWERPICC CATHETER2Cleared 510(K)
- K063363FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE2Cleared 510(K)
- K070615ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT2Cleared 510(K)
- K063848POWERGROSHONG PICC CATHETER2Cleared 510(K)
- K062579OMNIPICC P.I.2Cleared 510(K)
- K063240SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR2Cleared 510(K)
- K062425LIFECATH S PICC AND MIDLINE CATHETER2Cleared 510(K)
- K052475VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS2Cleared 510(K)
- K061289ARROW PRESSURE INJECTABLE PICC2Cleared 510(K)
- K061936KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 433112Cleared 510(K)
- K061179POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER2Cleared 510(K)
- K0619861.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S502Cleared 510(K)
- K061240SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES2Cleared 510(K)
- K060887ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT2Cleared 510(K)
- K053345PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D2Cleared 510(K)
- K053501POWERPICC2Cleared 510(K)
- K051672POWERPICC2Cleared 510(K)
- K051102OMNIPICC PI2Cleared 510(K)
- K051991POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE2Cleared 510(K)
- K050889FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH2Cleared 510(K)
- K051690VYGON NUTRILINE CATHETERS2Cleared 510(K)
- K050542MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER2Cleared 510(K)
- K051194BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 3846692Cleared 510(K)
- K041849TURBO-FLO PICC2Cleared 510(K)
- K0514176 FR FL POWERHOHN AND POWERLINE CATHETER2Cleared 510(K)
- K0509316 FR DL POWERPICC CATHETER2Cleared 510(K)
- K050185POWERHOHN AND POWERLINE CATHETERS2Cleared 510(K)
- K0435026 FR POLY PER-Q-CATH TRIPLE LUMEN PICC2Cleared 510(K)
- K030400NEOSCI MEDICAL ENDOLUMINAL BRUSH2Cleared 510(K)
- K042461KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 433042Cleared 510(K)
- K042491BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER2Cleared 510(K)
- K041088TRIFUSION, MODEL 0609190/06593502Cleared 510(K)
- K041468PREMICATH, 1261.2052Cleared 510(K)
- K042126PICC2Cleared 510(K)
- K041420ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT2Cleared 510(K)
- K033389POWERPICC CATHETERS, MODELS 3175155, 31751352Cleared 510(K)
- K040446ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT2Cleared 510(K)
- K034020GROSHONG NXT PICC CATHETERS2Cleared 510(K)
- K034019POLY PER-Q-CATH PICC CATHETERS2Cleared 510(K)
- K031718LIFEVALVE CENTRAL VENOUS CATHTER2Cleared 510(K)
- K031626ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT2Cleared 510(K)
- K031129POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC2Cleared 510(K)
- K030415ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT2Cleared 510(K)
- K0302703F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON2Cleared 510(K)
- K030255SILICONE DUAL LUMEN RADPICC CATHETERS2Cleared 510(K)
- K023374GROSHONG NXT DUAL LUMEN PICC CATHETERS2Cleared 510(K)
- K021704VAXCEL PICC WITH PASV VALVE TECHNOLOGY2Cleared 510(K)
- K012641FAS ENDOLUMINAL BRUSH2Cleared 510(K)
- K012902POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 32461002Cleared 510(K)
- K003839CENTRAL VENOUS CATHETER2Cleared 510(K)
- K010349DUAL LUMEN MIDLINE CATHETER2Cleared 510(K)
- K003682MEDCOMP Z-CATH2Cleared 510(K)
- K992424SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J202Cleared 510(K)
- K003642PLACEMENT-PLUS2Cleared 510(K)
- K003110MEDCOMP BIO-CATH CATHETER LINE2Cleared 510(K)
- K001874PERIPHERALLY INSERTED CENTRAL CATHETER2Cleared 510(K)
- K001901POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 31341352Cleared 510(K)
- K993442VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)2Cleared 510(K)
- K993052VYGON 2 FR EPICUTANEO PUR-CATHETER2Cleared 510(K)
- K993614FAS ENDOLUMINAL BRUSH2Cleared 510(K)
- K983544VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)2Cleared 510(K)
- K983412MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T2Cleared 510(K)
- K980090ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)2Cleared 510(K)
- K972555CATHETER TUNNELER2Cleared 510(K)
- K971999PERIPHERALLY INSERTED CENTRAL2Cleared 510(K)
- K9730571.4 FR MAPCATH SENSOR STYLET2Cleared 510(K)
- K970926DOUBLE LUMEN PICC2Cleared 510(K)
- K970269CLINICATH IR PERIPHERALLY INSERTED CATHETER2Cleared 510(K)
- K971085SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER2Cleared 510(K)
- K964929PERIPHERALLY INSERTED CENTRAL CATHETER2Cleared 510(K)
- K964556HR POLYURETHANE PICC AND MIDLINE CATHETERS2Cleared 510(K)
- K964447PICC CATHETER/MIDLINE CATHETER2Cleared 510(K)
- K970434NEO-PICC2Cleared 510(K)
- K963257PERIPHERALLY INSERTED MEDLINE CATHETER2Cleared 510(K)
- K963806CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)2Cleared 510(K)
- K963215CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)2Cleared 510(K)
- K963097CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)2Cleared 510(K)
- K962849CATHETER INSERTION TRAY2Cleared 510(K)
- K960055MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 89322Cleared 510(K)
- K962300CLAMPLESS VALVED CATHETER2Cleared 510(K)
- K961856AUTO SUTURE CHEMOSITE TUNNELER2Cleared 510(K)
- K961336MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 846522Cleared 510(K)
- K961155SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 719082Cleared 510(K)
- K954302VYGON PREMI-CATH - LONG TERM CATHETER2Cleared 510(K)
- K953300V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER2Cleared 510(K)
- K9546385 FR PICC-LINE CATHETER2Cleared 510(K)
- K954720STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS2Cleared 510(K)
- K954409PS MEDICAL IPI VASCULAR ACCESS CATHETER2Cleared 510(K)
- K954422PER-Q-CATH MID-LINE2Cleared 510(K)
- K954104PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES2Cleared 510(K)
- K953436STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM2Cleared 510(K)
- K953256STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS2Cleared 510(K)
- K952626MAPWIRE J-TIP SENSOR GUIDEWIRE2Cleared 510(K)
- K951078CATHETER, INTRAVASCULAR OR PERCUTANEOUS2Cleared 510(K)
- K945956STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS2Cleared 510(K)
- K951098HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER2Cleared 510(K)
- K950987STRATO/INFUSAID TUNNELER2Cleared 510(K)
- K946250STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS2Cleared 510(K)
- K944685CATO FIRST PICC-DUAL LUMEN2Cleared 510(K)
- K935145CYPERFLO PERIPHERALLY INSERTED CATHETER2Cleared 510(K)
- K935380VASCULAR ACCESS CATHETER ACCESSORIES2Cleared 510(K)
- K945499CATO FIRST PICC KIT2Cleared 510(K)
- K932464PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH.2Cleared 510(K)
- K932433PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE2Cleared 510(K)
- K932430DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER2Cleared 510(K)
- K932211PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS2Cleared 510(K)
- K932198PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH2Cleared 510(K)
- K930473ONECATH L-CATH CATHETER SYSTEM2Cleared 510(K)
- K930129ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER2Cleared 510(K)
- K925236L CATH(R) CATHETER SYSTEM2Cleared 510(K)
- K9263313.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH2Cleared 510(K)
- K926293ANGIOCOR SIDEHOLE INFUSION CATHETER2Cleared 510(K)
- K930630RIGHT ATRIAL CATHETER2Cleared 510(K)
- K933884STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K924851STRATO MEDICAL SINGLE LUMEN VALVED CATHETER2Cleared 510(K)
- K924677STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH2Cleared 510(K)
- K921751INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER2Cleared 510(K)
- K920755L-CATH PEEL AWAY SYSTEM CATHETER2Cleared 510(K)
- K923653NEEDLELESS INJECTION CANNULA2Cleared 510(K)
- K9217558 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS2Cleared 510(K)
- K911067NORCATH VASCULAR ACCESS CATHETERS2Cleared 510(K)
- K9104868 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER2Cleared 510(K)
- K910315PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K2Cleared 510(K)
- K910622GESCO PER-Q-CATH REPAIR KIT2Cleared 510(K)
- K903648VYGON LIFEVAC PICC2Cleared 510(K)
- K904334PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT2Cleared 510(K)
- K895543WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER2Cleared 510(K)
- K896598STRATO INDWELLING CATHETER2Cleared 510(K)
- K897168EPICUTANEO-CAVA CATHETER CODE 21842Cleared 510(K)
- K895712PERCUTANEOUS INTRAVENOUS CATHETERS2Cleared 510(K)
- K892926DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS2Cleared 510(K)
- K893126DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE2Cleared 510(K)
- K883313PMT VASCULAR CATHETER MODEL NUMBER 3621-12Cleared 510(K)
- K882448MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE2Cleared 510(K)
- K882100VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT2Cleared 510(K)
- K871998GROSHONG CV CATHETER REPAIR KIT2Cleared 510(K)
- K864086VAPOR-SEAL(TM) PERCUTANEOUS CATHETERS2Cleared 510(K)
- K861563VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT2Cleared 510(K)
- K851243GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION2Cleared 510(K)
- K851195VASCULAR ACCESS CATHETER2Cleared 510(K)
- K844080ARROW-GEISS PERCUTANEOUS TPN KIT2Cleared 510(K)
- K843450ARGYLE SILICONE CENTRAL VENOUS CATH-2Cleared 510(K)
- K841443REDO CENTRAL VENOUS CATHETER-NEONATE2Cleared 510(K)
- K841878SHEATH REMOVER2Cleared 510(K)
- K840742RIGHT ATRIAL CATHETER2Cleared 510(K)
- K840846STERILE HICHMAN/BROVIAC INJECTION CAP2Cleared 510(K)
- K834383DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT2Cleared 510(K)
- K834299LONG TERM CENTRAL VENOUS ACCESS CATH2Cleared 510(K)
- K834473MULTI-LUMEN CENTRAL VENOUS CATH. KIT2Cleared 510(K)
- K840958DESERET LONG TERM INDWELLING CATHETER2Cleared 510(K)
- K840681DAYPAK SYSTEM III CATHETER CARE KIT2Cleared 510(K)
- K833915VASCULAR ACCESS CATH. REPAIR KIT2Cleared 510(K)
- K833442PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM2Cleared 510(K)
- K834091SILCATH2Cleared 510(K)
- K834225RAAF DUAL LUMEN CATH. REPAIR KIT 2.22Cleared 510(K)
- K831802LIFE VAC #2191 & 21922Cleared 510(K)
- K832774REPAIR KITS FOR RIGHT ATRIAL CATH2Cleared 510(K)
- K832580RAAF CATHETER REPAIR KIT2Cleared 510(K)
- K831587TEMP. REPAIR KIT-DUAL LUMEN CATHETER2Cleared 510(K)
- K831386GROSHONG CATHETER, LONG TERM TYPE2Cleared 510(K)
- K831845PER-Q-CATH TRAY2Cleared 510(K)
- K830969PERM. REPAIR KIT FOR LEONARD NORTON DUAL2Cleared 510(K)
- K830406NON-STERILE CATHETER REPAIR KITS2Cleared 510(K)
- K830256NON-STERILE BROVIAC PARENTERAL ALIMI-2Cleared 510(K)
- K830233NON-STERILE,SINGLE/SOUBLE LUMEN-CATH2Cleared 510(K)
- K823553CORCATH H & B VASCULAR ACCESS CATHETER2Cleared 510(K)
- 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
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K152409
- 510(k) Type
- Special
- Applicant
- Navilyst Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/24/2015
- Days to Decision
- 29 days
- Submission Type
- Summary