Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- EZTPacemaker, Bladder3Product Code
- EZWStimulator, Electrical, Implantable, For Incontinence3Product Code
- EZYDevice, Incontinence, Mechanical/Hydraulic3Product Code
- FAHDilator, Urethral, Mechanical2Product Code
- BSSTube, Nasogastric2Product Code
- EXASelector, Size, Ostomy1Product Code
- EXBCollector, Ostomy1Product Code
- EXDIrrigator, Ostomy2Product Code
- EXEProtector, Ostomy1Product Code
- EXFBag, Bile Collecting2Product Code
- EXGBag, Urine Collecting, Ureterostomy1Product Code
- EXHBag, Urinary, Ileostomy1Product Code
- EXIDevice, Paste-On For Incontinence, Sterile1Product Code
- EXJDevice, Incontinence, Urosheath Type, Sterile1Product Code
- EXNSupport, Hernia1Product Code
- EYAStylet, Ureteral1Product Code
- EYBCatheter, Ureteral, Gastro-Urology2Product Code
- EYCCatheter, Upper Urinary Tract2Product Code
- EYIAdaptor, Ureteral Catheter1Product Code
- EYJHolder, Ureteral Catheter1Product Code
- EYKConnector, Ureteral Catheter1Product Code
- EYQGarment, Protective, For Incontinence1Product Code
- EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile1Product Code
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile1Product Code
- EZBStylet For Catheter, Gastro-Urology1Product Code
- EZCCatheter, Coude2Product Code
- EZDCatheter, Straight2Product Code
- EZKCatheter, Retention Type2Product Code
- EZLCatheter, Retention Type, Balloon2Product Code
- EZMDilator, Esophageal (Metal Olive) Gastro-Urology2Product Code
- EZNDilator, Catheter, Ureteral2Product Code
- EZQPouch, Colostomy1Product Code
- EZRCement, Stomal Appliance, Ostomy1Product Code
- EZSAppliance, Colostomy, Disposable1Product Code
- FAQBag, Urine Collection, Leg, For External Use, Sterile1Product Code
- FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology2Product Code
- FAXBougie, Urological1Product Code
- FBMCannula And Trocar, Suprapubic, Non-Disposable1Product Code
- FBRUrethrometer1Product Code
- FBWFiliform And Filiform Follower1Product Code
- FBXSound, Urethral, Metal Or Plastic1Product Code
- FCBBag, Hemostatic2Product Code
- FCEEnema Kit1Product Code
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)2Product Code
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter2Product Code
- FEFTube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression2Product Code
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation2Product Code
- FEWCatheter, Malecot2Product Code
- FEXInstrument, Catheter, Punch1Product Code
- FEZCatheter And Tube, Suprapubic2Product Code
- FFATube, Drainage, Suprapubic2Product Code
- FFHCollector, Urine, Pediatric, For Indwelling Catheter2Product Code
- FFPDilator, Rectal1Product Code
- FFWString And Tubes, Gastrointestinal, To Locate Internal Bleeding2Product Code
- FGDCatheter, Retention, Barium Enema With Bag2Product Code
- FGEStents, Drains And Dilators For The Biliary Ducts2Product Code
- FGFCatheter, Ureteral Disposable (X-Ray)2Product Code
- FGHCatheter, Double Lumen Female Urethrographic2Product Code
- FGICatheter, Urethrographic, Male2Product Code
- FHAClamp, Penile1Product Code
- FHSDialyzer, Single Coil2Product Code
- FHTSet, Gavage, Infant, Sterile2Product Code
- FIAChair, Dialysis, Unpowered, Without Scales1Product Code
- FIBProtector, Transducer, Dialysis2Product Code
- FIDTubing, Dialysate2Product Code
- FIENeedle, Fistula2Product Code
- FIFSet, Dialysis, Single Needle With Uni-Directional Pump2Product Code
- FIGClamp, Tubing, Blood, Automatic2Product Code
- FIHPump, Infusion Or Syringe, Extra-Luminal2Product Code
- FIISystem, Dialysate Delivery, Sealed2Product Code
- FIJSystem, Dialysate Delivery, Recirculating, Single Pass2Product Code
- FIKSystem, Dialysate Delivery, Recirculating2Product Code
- FILSystem, Dialysate Delivery, Single Pass2Product Code
- FINTank, Holding, Dialysis2Product Code
- FIPSubsystem, Water Purification2Product Code
- FIQCannula, A-V Shunt2Product Code
- FIRPump, Blood, Extra-Luminal2Product Code
- FISFlowmeter, Dialysate2Product Code
- FIWAlarm, Pillow Pressure2Product Code
- FIZMeter, Conductivity, Non-Remote2Product Code
- FJAManometer, Water2Product Code
- FJBDetector, Dialysate Level2Product Code
- FJCDetector, Blood Level2Product Code
- FJDDetector, Leak, Blood2Product Code
- FJFDetector, Air Bubble2Product Code
- FJGDialyzer, Parallel Flow2Product Code
- FJHDialyzer, Disposable2Product Code
- FJIDialyzer, Capillary, Hollow Fiber2Product Code
- FJJDialyzer, Twin Coil2Product Code
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2Product Code
- FJMGuard, Shunt2Product Code
- FJNStabilizer, Shunt2Product Code
- FJOPlier, Tube1Product Code
- FJPAdaptor, Y2Product Code
- FJQConnector, Shunt1Product Code
- FJRForceps, Disconnect1Product Code
- FJSCatheter, Peritoneal, Long-Term Indwelling2Product Code
- FJTIntracatheter, Dialysis2Product Code
- FJWRing, Joint1Product Code
- FJXRing, Crimp1Product Code
- FJYPlier, Crimp1Product Code
- FJZDeclotting Tray, Kit (Including Contents)2Product Code
- FKADilator, Vessel2Product Code
- FKBConnector, Blood Tubing, Infusion T2Product Code
- FKCClamp, Cannula1Product Code
- FKDCanister, Coil2Product Code
- FKETie, Dialysis1Product Code
- FKFGun, Tie, Dialysis1Product Code
- FKGTray, Start/Stop (Including Contents), Dialysis1Product Code
- FKHSolution-Test Standard-Conductivity, Dialysis2Product Code
- FKISet, Dialyzer Holder2Product Code
- FKJFilter, Blood, Dialysis2Product Code
- FKLInsert, Pump, Blood2Product Code
- FKMAdaptor, Fistula2Product Code
- FKNAdaptor, Shunt2Product Code
- FKOCatheter, Peritoneal Dialysis, Single Use2Product Code
- FKPSystem, Dialysate Delivery, Single Patient2Product Code
- FKQSystem, Dialysate Delivery, Central Multiple Patient2Product Code
- FKRSubsystem, Proportioning2Product Code
- FKTSystem, Dialysate Delivery, Sorbent Regenerated2Product Code
- FKWTip, Vessel2Product Code
- FKXSystem, Peritoneal, Automatic Delivery2Product Code
- FKYConnector, Tubing, Dialysate2Product Code
- FLAMonitor, Temperature, Dialysis2Product Code
- FLBMeter, Conductivity, Induction, Remote Type2Product Code
- FLCStation, Dialysis Control, Negative Pressure Type2Product Code
- FLDApparatus, Hemoperfusion, Sorbent2Product Code
- FOCBag, Urine Collection, Newborn2Product Code
- FONBag, Drainage, With Adhesive, Ostomy1Product Code
- FPDTube, Feeding2Product Code
- FRQTube, Levine2Product Code
- GBLCatheter, Ureteral, General & Plastic Surgery2Product Code
- GBMCatheter, Urethral2Product Code
- GBTCatheter, Rectal2Product Code
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection2Product Code
- GDSBag, Stomal1Product Code
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration2Product Code
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System2Product Code
- KDJSet, Administration, For Peritoneal Dialysis, Disposable2Product Code
- KDKContainer, Transport, Kidney2Product Code
- KDLSet, Perfusion, Kidney, Disposable2Product Code
- KDNSystem, Perfusion, Kidney2Product Code
- KGCTube, Gastro-Enterostomy2Product Code
- KNQDilator, Esophageal2Product Code
- KNRAdapter, A-V Shunt Or Fistula2Product Code
- KNTTubes, Gastrointestinal (And Accessories)2Product Code
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter2Product Code
- KNYAccessories, Catheter, G-U2Product Code
- KNZAccessories, A-V Shunt2Product Code
- KOBCatheter, Suprapubic (And Accessories)2Product Code
- KOCAccessories, Blood Circuit, Hemodialysis2Product Code
- KODCatheter, Urological2Product Code
- KOEDilator, Urethral2Product Code
- KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal2Product Code
- KPHCatheter, Rectal For Continent Ileostomy1Product Code
- KPIStimulator, Electrical, Non-Implantable, For Incontinence2Product Code
- KPLColonic Irrigation System2Product Code
- KPMShunt, Peritoneal2Product Code
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)2Product Code
- KPPPeritoneal Dialysate Filter2Product Code
- KQQTubing, Dialysate (And Connector)2Product Code
- KQRDetector, Air Or Foam2Product Code
- KXMSystem Accessories, Extracorporeal2Product Code
- LBWSet, Dialysis, Single Needle (Co-Axial Flow)2Product Code
- LCGIntestinal Splinting Tubes2Product Code
- LFJCatheter, Subclavian2Product Code
- LFKCatheter, Femoral2Product Code
- LIFDialyzer Reprocessing System2Product Code
- LJHSystem, Irrigation, Urological2Product Code
- LKYDevice, External Penile Rigidity2Product Code
- LLBSystem, Blood, Extracorporeal And Accessories2Product Code
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological2Product Code
- LQRDislodger, Stone, Biliary2Product Code
- LRIPh Meter For Dialysis Hydrogen Ion Concentration2Product Code
- MJCCatheter, Urological (Antimicrobial) And Accessories2Product Code
- MLWWarmer, Peritoneal Dialysate2Product Code
- MNGExternal Urethral Occluder, Urinary Incontinence-Control, Female1Product Code
- MNVStrip, Dialysate Ph Indicator2Product Code
- MONSystem, Hemodialysis, Remote Accessories1Product Code
- MPBCatheter, Hemodialysis, Non-Implanted2Product Code
- MQSSystem, Hemodialysis, Access Recirculation Monitoring2Product Code
- MSBSystem And Accessories, Isolated Heart, Transport And Preservation2Product Code
- MSDCatheter, Hemodialysis, Implanted2Product Code
- K241581Hemodialysis Catheter2Cleared 510(K)
- K210461End Cap2Cleared 510(K)
- K203575GlidePath Retro Long-Term Hemodialysis Catheter2Cleared 510(K)
- K211410GlidePath 13F Long-Term Hemodialysis Catheter2Cleared 510(K)
- K203767Pristine Long-Term Hemodialysis Catheter2Cleared 510(K)
- K202150GlidePath 7.5F Long-Term Dialysis Catheter2Cleared 510(K)
- K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes2Cleared 510(K)
- K200627GlidePath 10F Long-Term Dialysis Catheter2Cleared 510(K)
- K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters2Cleared 510(K)
- K182443Pristine Hemodialysis Catheter2Cleared 510(K)
- K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes2Cleared 510(K)
- K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)2Cleared 510(K)
- K171571NexSite HD, Hemodialysis Step Tip Catheter (60cm)2Cleared 510(K)
- K171618Symetrex Long Term Hemodialysis Catheter2Cleared 510(K)
- K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)2Cleared 510(K)
- K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter2Cleared 510(K)
- K143567NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)2Cleared 510(K)
- K140884SYMETREX LONG TERM HEMODIALYSIS CATHETER2Cleared 510(K)
- K140492NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE2Cleared 510(K)
- K141051VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU2Cleared 510(K)
- K141363CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER2Cleared 510(K)
- K130889SPLIT CATH RG2Cleared 510(K)
- K131260NMI DIALYSIS CATHETER2Cleared 510(K)
- K133796NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),2Cleared 510(K)
- K130851CASCADE HEMODIALYSIS/APHERESIS CATHETER2Cleared 510(K)
- K131814AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER2Cleared 510(K)
- K130192NEXTSTEP RETROGRADE2Cleared 510(K)
- K123943AMECATH DUAL LUMEN HEMODIALYSIS CATHETER2Cleared 510(K)
- K121933NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)2Cleared 510(K)
- K123196PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH2Cleared 510(K)
- K121848SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM2Cleared 510(K)
- K113487HEMO-CATH 10F, HEMO-CATH 12.5F2Cleared 510(K)
- K111651SPLIT CATH III2Cleared 510(K)
- K111817PALINDROME RT CHRONIC CATHETER2Cleared 510(K)
- K111900NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER2Cleared 510(K)
- K111372TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...2Cleared 510(K)
- K111117CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...2Cleared 510(K)
- K110936DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT2Cleared 510(K)
- K102238ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER2Cleared 510(K)
- K102043ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER2Cleared 510(K)
- K101843DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT2Cleared 510(K)
- K100169DURASPAN HEMODIALYSIS LONG-TERM CATHETER2Cleared 510(K)
- K091506DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 621555202Cleared 510(K)
- K092597CENTROS CHRONIC HEMODIALYSIS CATHETER SET2Cleared 510(K)
- K092205PALINDROME P HEMODIALYSIS CATHETER2Cleared 510(K)
- K091760DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)2Cleared 510(K)
- K090528DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT2Cleared 510(K)
- K090148PROGUIDE CHRONIC DIALYSIS CATHETER2Cleared 510(K)
- K090101EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS2Cleared 510(K)
- K080400ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT2Cleared 510(K)
- K073092DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,2Cleared 510(K)
- K073093DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,2Cleared 510(K)
- K071202DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)2Cleared 510(K)
- K072499NOVOFLO CATHETER LT2Cleared 510(K)
- K07142215.5F HEMO-STREAM HEMODIALYSIS CATHETER SET2Cleared 510(K)
- K070572ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM2Cleared 510(K)
- K06344115.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH552Cleared 510(K)
- K062901HEMOCATH II2Cleared 510(K)
- K06343115.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH402Cleared 510(K)
- K06267114.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)2Cleared 510(K)
- K060288RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS2Cleared 510(K)
- K060972KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)2Cleared 510(K)
- K06015515.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS2Cleared 510(K)
- K053589LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING2Cleared 510(K)
- K051280MEDCOMP SPLIT CATH II2Cleared 510(K)
- K05158414.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY2Cleared 510(K)
- K051748HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS2Cleared 510(K)
- K04267214F DUAL FLOATING DIALYSIS CATHETER/TRAY2Cleared 510(K)
- K043292HEMOCATH2Cleared 510(K)
- K040318MEDCOMP SPLIT-CATH II2Cleared 510(K)
- K043272PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP2Cleared 510(K)
- K04285855CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS2Cleared 510(K)
- K04032815.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER2Cleared 510(K)
- K041914PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER2Cleared 510(K)
- K042016DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER2Cleared 510(K)
- K04155955CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH552Cleared 510(K)
- K04099215F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 103007062Cleared 510(K)
- K041006TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR2Cleared 510(K)
- K040736VAXCEL PLUS CHRONIC DIALYSIS CATHETER2Cleared 510(K)
- K040666STEP-TIP CHRONIC HEMODIALYSIS CATHETER2Cleared 510(K)
- K040509ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH402Cleared 510(K)
- K040402ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT2Cleared 510(K)
- K040492VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER2Cleared 510(K)
- K040260INTEGRAL HEMODIALYSIS CATHETER2Cleared 510(K)
- K033676PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER2Cleared 510(K)
- K040078CANNON II PLUS2Cleared 510(K)
- K032061DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH2Cleared 510(K)
- K023023LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA2Cleared 510(K)
- K033294HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER2Cleared 510(K)
- K032712VAXCEL PLUS CHRONIC DIALYSIS CATHETER2Cleared 510(K)
- K030277SOFT-CELL DUAL LUMEN CATHETERS2Cleared 510(K)
- K030020HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER2Cleared 510(K)
- K03050214.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-552Cleared 510(K)
- K022662DIATEK CANNON-CATHETER, MODEL CC55002Cleared 510(K)
- K023847HEMO-STREAM HEMODIALYSIS CATHETER SET2Cleared 510(K)
- K030983TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY2Cleared 510(K)
- K022678MEDCOMP SC42Cleared 510(K)
- K022905LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER2Cleared 510(K)
- K02093610F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL2Cleared 510(K)
- K02175914F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT552Cleared 510(K)
- K022000POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)2Cleared 510(K)
- K02031514F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL2Cleared 510(K)
- K020465MEDCOMP ASH SPLIT-CATH II2Cleared 510(K)
- K02121224CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS2Cleared 510(K)
- K013160POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER2Cleared 510(K)
- K012562MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER2Cleared 510(K)
- K011916SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES2Cleared 510(K)
- K012948MODIFICATION TO VAXCEL DIALYSIS CATHETER2Cleared 510(K)
- K010306MEDCOMP EXCELL SPLIT TIP CATHETER2Cleared 510(K)
- K994105HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-402Cleared 510(K)
- K012365VAXCEL DIALYSIS CATHETER2Cleared 510(K)
- K010399DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)2Cleared 510(K)
- K003207MEDCOMP ULTRA-FLOW CATHETER2Cleared 510(K)
- K002902TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS2Cleared 510(K)
- K010567OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR2Cleared 510(K)
- K002901KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER2Cleared 510(K)
- K001633LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK00002Cleared 510(K)
- K982326MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY2Cleared 510(K)
- K981125MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-62Cleared 510(K)
- K982333MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY2Cleared 510(K)
- K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS2Cleared 510(K)
- K981994VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER2Cleared 510(K)
- K972207MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM2Cleared 510(K)
- K971925MEDCOMP BIO-FLEX CS CATHETER (CS100)2Cleared 510(K)
- MSEHemodialyzer, Re-Use, Low Flux2Product Code
- MSFHemodialyzer, Re-Use, High Flux2Product Code
- MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant2Product Code
- MSZStrip, Test, Reagent, Residuals For Dialysate2Product Code
- NAMStimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction2Product Code
- NDSMedia, Culture, Ex Vivo, Tissue And Cell2Product Code
- NFKKit, Repair, Catheter, Hemodialysis2Product Code
- NHVSystem, Water Purification, General Medical Use2Product Code
- NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted2Product Code
- NIFCatheter, Hemodialysis, Triple Lumen, Implanted2Product Code
- NMLCatheter, Biliary, Reprocessed2Product Code
- NNENeedle, Fistula, Reprocessed2Product Code
- NNGSet, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed2Product Code
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile1Product Code
- NNXDevice, Incontinence, Urosheath Type, Non-Sterile1Product Code
- NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NOADevice, Paste-On For Incontinence, Non-Sterile1Product Code
- NOOClamp, Dialysis Arm1Product Code
- NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia2Product Code
- NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use2Product Code
- NTZStrip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator2Product Code
- NUBColonic Irrigation System, General Well Being3Product Code
- NYUCatheter, Hemodialysis, Implanted, Coated2Product Code
- NWOKit, Catheter, Urinary (Exludes Hiv Testing)2Product Code
- NWPSuprapubic Cystostomy Catheter Kit2Product Code
- NWQKit, Catheter, External, Male (Excludes Hiv Testing)2Product Code
- NWRKit, Catheter, Foley (Excludes Hiv Testing)2Product Code
- NZUCollector, Urine, Powered, Non Indwelling Catheter1Product Code
- ODNUltrafiltration-Controlled Nocturnal Dialysate Delivery System2Product Code
- ODXAutonomous Extracorporeal Blood Leak Detector/Alarm2Product Code
- OHRCatheter Care Tray2Product Code
- ONWHemodialysis System For Home Use2Product Code
- ONYOral Removable Retainer For Weight Management2Product Code
- PBPRectal Insert2Product Code
- PCUPancreatic Stent, Covered, Metallic, Removable2Product Code
- PEHHemodialysis Catheter Luer End Cap2Product Code
- PEVDialysis Administration Kit2Product Code
- PEWImplantable Transprostatic Tissue Retractor System2Product Code
- PFHVenous Window Needle Guide2Product Code
- PIAVibrator For Climax Control Of Premature Ejaculation2Product Code
- PIDEsophageal Dilator Balloon With Or Without Electrode Sensors2Product Code
- PIEEsophageal Dilator With Balloon And Electrode Sensors2Product Code
- PIFGastrointestinal Tubes With Enteral Specific Connectors2Product Code
- QGCSuprapubic Catheter Accessories1Product Code
- PIHUrethral Insert With Pump For Bladder Drainage2Product Code
- PINKidney Perfusion Kit2Product Code
- PIOEnteral Specific Transition Connectors2Product Code
- PJHDynamic Rectal Control System2Product Code
- PKIFully Subcutaneous Implanted Hemodialysis Catheter2Product Code
- PLIGastrointestional Tube Holder2Product Code
- PLQEnzyme Packed Cartridge2Product Code
- PNBBiliary Stent System For Benign Strictures2Product Code
- PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling2Product Code
- PNREnteral Syringes With Enteral Specific Connectors2Product Code
- QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss2Product Code
- PPABladder Irrigation Kit2Product Code
- PPBFoley Catheter Kit (Excludes Hiv Testing)2Product Code
- PPCMale External Catheterization Kit (Excludes Hiv Testing)2Product Code
- PPDUniversal Drainage Tray2Product Code
- PPFUrinary Irrigation Kit2Product Code
- PPGUrinary Drainage Collection Kit2Product Code
- PPHSingle Needle With Uni-Directional Pump Kit2Product Code
- PPIHemodialysis Tray (Not A Start/Stop Kit)2Product Code
- PPJPeritoneal Dialysis Administration Kit2Product Code
- PPKPeritoneal Dialysis Tubing Kit2Product Code
- PPLSingle Needle (Co-Axial Flow) Dialysis Kit2Product Code
- PPOMulti-Lumen Hemodialysis Catheterization Kit2Product Code
- PQEOstomy Care Kit1Product Code
- PRMEnteral Administration Kit (Adult & Pediatric)2Product Code
- PROAnti-Regurgitation Blood Tubing Kit2Product Code
- PRPBalloon Gastrostomy Tube Kit2Product Code
- PRQEsophageal Dilator Kit2Product Code
- PRRFeeding Tube Kit2Product Code
- PRSGastric Colonic Catheter Irrigation Kit2Product Code
- PRTGastric Irrigation And Aspiration Kit2Product Code
- PRWGastrointestinal Tube Kit2Product Code
- PRXGastrostomy Guide Wire Placement Kit2Product Code
- PRYGastrostomy Jejunostomy Feeding Tube Kit2Product Code
- PRZGastrostomy Tube Kit2Product Code
- PSALaparoscopic Jejunostomy Kit2Product Code
- PSBNasogastric Feed Tube Kit2Product Code
- PSCNasogastric-Gastrojejunal Kit2Product Code
- PSDLaparoscopic Gastrostomy Kit2Product Code
- PSENeedle Catheter Jejunostomy Kit2Product Code
- PSFNon-Balloon Replacement Gastrostomy System2Product Code
- PSGPercutaneous Endoscopic Gastrostomy Kit2Product Code
- PSHPercutaneous Replacement Gastrostomy Tube Kit2Product Code
- PSJRectal Dilator Kit1Product Code
- PSKReplacement Gastrostomy Feeding Catheter Tray2Product Code
- PSXChlorine Meter2Product Code
- PTKPediatric Esophageal Atresia Anastomosis Device3Product Code
- PTTBiliary Catheter For Irrigation And Contrast Injection, Exempt2Product Code
- PTUCatheter, Peritoneal, Long-Term Indwelling, Exempt2Product Code
- PTVCatheter, Peritoneal Dialysis, Single Use, Exempt2Product Code
- PTWSystem, Peritoneal, Automatic Delivery, Exempt2Product Code
- QAJCutaneous Electrode Stimulator For Urinary Incontinence2Product Code
- QAXHemodialyzer With Expanded Solute Removal Profile2Product Code
- QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories1Product Code
- QGEBiliary Stent, Drain, And Dilator Accessories1Product Code
- QIRPediatric Hemodialysis System2Product Code
- QJNLaparoscopic Accessories, Esophageal Sizing2Product Code
- QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia2Product Code
- QMYComputerized Behavioral Therapy Device For Treating Symptoms2Product Code
- QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence3Product Code
- QRCNon-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation2Product Code
- SCTFoley Catheters And Accessories With Additional Safety Features2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
- 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
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K063431
- 510(k) Type
- Traditional
- Applicant
- Spire Biomedical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/29/2007
- Days to Decision
- 77 days
- Submission Type
- Summary