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
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports2Cleared 510(K)
- K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port2Cleared 510(K)
- K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports2Cleared 510(K)
- K181446Bard Power-Injectable Implantable Ports (PowerPorts®)2Cleared 510(K)
- K151239NMI DUAL PORT II2Cleared 510(K)
- K153359BardPort®, SlimPort®, and X-Port® Implanted Ports2Cleared 510(K)
- K153238Dignity Dual Port2Cleared 510(K)
- K153228NMI Port, NMI Port II2Cleared 510(K)
- K150514Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters2Cleared 510(K)
- K150733Vital-Port Vascular Access System Power Injectable Port2Cleared 510(K)
- K141146INVISIPORT2Cleared 510(K)
- K140169VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K133335POWERPORT IMPLANTABLE PORT2Cleared 510(K)
- K132177MEDCOMP GEN III POWER INJECTABLE PORT2Cleared 510(K)
- K122834POLYSITE IMPLANTABLE INFUSION PORTS2Cleared 510(K)
- K131694NMI PORT II CATHETER2Cleared 510(K)
- K1309235F DIGNITY CT TITANIUM PORT2Cleared 510(K)
- K122402LPP (LOW PROFILE PORT)2Cleared 510(K)
- K122767NMI PORT2Cleared 510(K)
- K130576CELSITE IMPLANTABLE ACCESS PORT SYSTEMS2Cleared 510(K)
- K122899POWERPORT CLEARVUE SLIM IMPLANTABLE PORT2Cleared 510(K)
- K120281DIGNITY POWER INJECTABLE TITANIUM PORT2Cleared 510(K)
- K110424DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL2Cleared 510(K)
- K112713NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS2Cleared 510(K)
- K110407INVISIPORT2Cleared 510(K)
- K111101NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET2Cleared 510(K)
- K102385NORFOLK MEDICAL NORPORT FAMILY OF PORTS2Cleared 510(K)
- K101017ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS2Cleared 510(K)
- K093414PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS2Cleared 510(K)
- K091099C-PORT - HP POWER INJECTABLE PORT2Cleared 510(K)
- K090512POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER2Cleared 510(K)
- K082126RHAPSODY MRI2Cleared 510(K)
- K081889RHAPSODY CT2Cleared 510(K)
- K081425COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT2Cleared 510(K)
- K081472SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS2Cleared 510(K)
- K081311POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER2Cleared 510(K)
- K080645STD MED PRIMO PORT POLY2Cleared 510(K)
- K072481JET PORT PLUS HP CATHETER SYSTEM2Cleared 510(K)
- K073423MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER2Cleared 510(K)
- K072657POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS2Cleared 510(K)
- K073210MODIFICATION TO: T-PORT HP INFUSION PORT2Cleared 510(K)
- K072549TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER2Cleared 510(K)
- K072215TITANIUM POWERPORT ISP IMPLANTED PORT2Cleared 510(K)
- K071993T-PORT HP INFUSION PORT2Cleared 510(K)
- K070911STD MED PRIMO PORT2Cleared 510(K)
- K070116POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE2Cleared 510(K)
- K070003POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)2Cleared 510(K)
- K062414VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET2Cleared 510(K)
- K063377POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER2Cleared 510(K)
- K061424CELSITE/ CELSITE CONCEPT, ACCESS PORTS2Cleared 510(K)
- K060812POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE2Cleared 510(K)
- K060036PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER2Cleared 510(K)
- K043178GRANTALDER RHAPSODY ACCESS PORT AND CATHETER2Cleared 510(K)
- K050310BARDPORT TITANIUM PORTS2Cleared 510(K)
- K050176VORTEX EZ VASCULAR ACCESS PORT2Cleared 510(K)
- K033686PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM2Cleared 510(K)
- K034065MODIFICATION TO X-PORT DUO PORT2Cleared 510(K)
- K033473MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT2Cleared 510(K)
- K032754VORTEX MP2Cleared 510(K)
- K032600VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-2332Cleared 510(K)
- K032557TRIUMPH VTX WITH LIFEVALVE CATHETER2Cleared 510(K)
- K032375VAXCEL PORT, MODELS 45-336 AND 45-3382Cleared 510(K)
- K031282OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-052Cleared 510(K)
- K031844VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-2382Cleared 510(K)
- K032008VAXCEL WITH PASV PORT, MODEL 45-2132Cleared 510(K)
- K032044X-PROT DUO PORT2Cleared 510(K)
- K030636C-PORT2Cleared 510(K)
- K021580OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-052Cleared 510(K)
- K030083VAXCEL WITH PASV PORT2Cleared 510(K)
- K022983BARDPORT X-PORT ISP PORT2Cleared 510(K)
- K022110KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.2Cleared 510(K)
- K010767LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES2Cleared 510(K)
- K010426PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER2Cleared 510(K)
- K010189VORTEX ACCESS SYSTEM2Cleared 510(K)
- K003006TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION2Cleared 510(K)
- K002770IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-102Cleared 510(K)
- K000125JET PORT PLUS CATHETER SYSTEM2Cleared 510(K)
- K993024CELSITE IMPLANTABLE PORT WITH VALVED CATHETER2Cleared 510(K)
- K994196HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM2Cleared 510(K)
- K994216PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM2Cleared 510(K)
- K994111CELSITE, MODELS ST401L, ST405L2Cleared 510(K)
- K993860CATHETER INNOVATIONS IMPLANTABLE PORT2Cleared 510(K)
- K992697PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM2Cleared 510(K)
- K991897CATHETER INNOVATIONS IMPLANTABLE PORT2Cleared 510(K)
- K992880P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM2Cleared 510(K)
- K983480BPOS-IVAD STABILIZER2Cleared 510(K)
- K982888VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K982507MINI POLYURETHANE CATHETER2Cleared 510(K)
- K974533TRIMPORT2Cleared 510(K)
- K974475THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 10122Cleared 510(K)
- K974829NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)2Cleared 510(K)
- K974471PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A2Cleared 510(K)
- K973497HUBERLOC2Cleared 510(K)
- K973862PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS2Cleared 510(K)
- K971582NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET2Cleared 510(K)
- K971140VITAL-PORT INFUSION PAL2Cleared 510(K)
- K970442TARGET VITAL-PORT VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K964117NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE2Cleared 510(K)
- K964538R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K964066DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)2Cleared 510(K)
- K964559PORTSMART NEEDLE DE-ACCESS ENCLOSURE2Cleared 510(K)
- K962230CELSITE PORT WITH PRECONNECTED CATHETER2Cleared 510(K)
- K963684A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)2Cleared 510(K)
- K962695PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER2Cleared 510(K)
- K962751IDEAS' DUAL PORT2Cleared 510(K)
- K961580PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS2Cleared 510(K)
- K961652LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #10172Cleared 510(K)
- K961615LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #10372Cleared 510(K)
- K961583A PORT DETACHED CATHETER SYSTEM CATALOG #10022Cleared 510(K)
- K954258TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)2Cleared 510(K)
- K960572THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER2Cleared 510(K)
- K952435CELSITE PEDIATRIC VENOUS SYSTEM2Cleared 510(K)
- K960350THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 16022Cleared 510(K)
- K955819A2 DETACHED DUAL PORT SYSTEM2Cleared 510(K)
- K955587VASCULAR ACCESS PORT KIT2Cleared 510(K)
- K955407PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS2Cleared 510(K)
- K953529STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM2Cleared 510(K)
- K954297CELSITE VENOUS ACCESS SYSTEM OTW2Cleared 510(K)
- K953254STRATO/INFUSAID INFUSE-A-KIT2Cleared 510(K)
- K954433VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K935767SIMS SILO NEEDLE DE-ACCESS ENCLOSURE2Cleared 510(K)
- K953571VASPORT VASCULAR ACCESS PORT2Cleared 510(K)
- K953073LOW PROFILE TITANIUM MODEL CATALOG #10032Cleared 510(K)
- K953110LOW PROFILE TITANIUM MODEL CATALOG #10032Cleared 510(K)
- K953017LOW PROFILE TITANIUM MODEL CATALOG #10032Cleared 510(K)
- K951814TRIUMPH-1 PORT2Cleared 510(K)
- K952748AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**2Cleared 510(K)
- K951077VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K952548CELSITE VENOUS SYSTEM2Cleared 510(K)
- K952537THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.2Cleared 510(K)
- K946189INTROPORT(TM) CATHETER MODEL #1000(ICT)2Cleared 510(K)
- K951076VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K945752CELSITE(TM) BRACHIAL VENOUS PORT2Cleared 510(K)
- K951875STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM2Cleared 510(K)
- K951874STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM2Cleared 510(K)
- K951873STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM2Cleared 510(K)
- K951872STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM2Cleared 510(K)
- K942784NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED2Cleared 510(K)
- K945551CELSITE(TM) DUAL VENOUS SYSTEM2Cleared 510(K)
- K950212A2 DETACHED DUAL PORT SYSTEM2Cleared 510(K)
- K9501311.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL2Cleared 510(K)
- K945250TRIMPORT2Cleared 510(K)
- K942848STRATO MEDICAL LIFEPORT LPS 75152Cleared 510(K)
- K934518STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM2Cleared 510(K)
- K926139CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH2Cleared 510(K)
- K932411VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA2Cleared 510(K)
- K934520VITAL-PORT VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K942623TRIMPORT2Cleared 510(K)
- K942412THEREX LOW-PROFILE PORT - TITANIUM MODEL2Cleared 510(K)
- K942103L-CATH CATHETER SYSTEM - PORT L-CATH2Cleared 510(K)
- K942024PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM2Cleared 510(K)
- K934796IPI LOW PROFILE IMPORT2Cleared 510(K)
- K934167IPI DUAL LUMEN PORT2Cleared 510(K)
- K936012THEREX LOW PROFILE PORT-TITANIUM MODEL2Cleared 510(K)
- K934802THEREX LOW-PROFILE PORT-TITANIUM2Cleared 510(K)
- K934792THEREX LOW-PROFILE PORT2Cleared 510(K)
- K934640HMP DUAL POLYSULFONE PORT2Cleared 510(K)
- K934573HMP TITANIUM LOW PROFILE PORT2Cleared 510(K)
- K934504HMP DUAL TITANIUM PORT2Cleared 510(K)
- K933990HMP TITANIUM PORT2Cleared 510(K)
- K933986HMP POLYSULFONE PORT2Cleared 510(K)
- K931748CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS2Cleared 510(K)
- K930206PS MEDICAL IPI ACCESS KIT2Cleared 510(K)
- K933350THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM2Cleared 510(K)
- K933316THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM2Cleared 510(K)
- K932447THEREX LOW-PROFILE PORT .6MM I.D 2.3MM O.D.2Cleared 510(K)
- K932671THEREX R-PORT2Cleared 510(K)
- K932010V.A.D. ACCESS KIT2Cleared 510(K)
- K932509STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT2Cleared 510(K)
- K932841PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS2Cleared 510(K)
- K932840PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K932095PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S2Cleared 510(K)
- K924250PLASTIC LOW PROFILE SUBCUTANEOUS PORT2Cleared 510(K)
- K924748VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P2Cleared 510(K)
- K921902PORT ACCESS NEEDLE2Cleared 510(K)
- K915273LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 55552Cleared 510(K)
- K924505SNAP-LOCK MICROPORT - REVISED2Cleared 510(K)
- K925373THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D2Cleared 510(K)
- K923019PHARMACIA DELTEC WINGED INFUSION SET2Cleared 510(K)
- K922896VITAL-PORT VASCULAR ACCESS SYSTEM W/ INJECTROL2Cleared 510(K)
- K926011A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI2Cleared 510(K)
- K922147DUAL PLASTIC VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K920036SURECATH PORT ACCESS CATHETER2Cleared 510(K)
- K922419IPI IMPORT2Cleared 510(K)
- K922434A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT2Cleared 510(K)
- K921379A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT2Cleared 510(K)
- K921475A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM2Cleared 510(K)
- K921201VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST.2Cleared 510(K)
- K910448SNAP-LOCK MICRO PORT, MODIFICATION2Cleared 510(K)
- K912702PLASTIC ATTACHABLE DUAL PORT2Cleared 510(K)
- K912540CONTOUR-PORT2Cleared 510(K)
- K913350VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K912465VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 11212Cleared 510(K)
- K912423VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,71122Cleared 510(K)
- K912424VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 71102Cleared 510(K)
- K911449VITAL-PORT VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K911055A-PORT IMPLANT VASC ACCESS SYST LINE EXT-A2 PORT2Cleared 510(K)
- K905838STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED2Cleared 510(K)
- K905839STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED2Cleared 510(K)
- K905845STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED2Cleared 510(K)
- K905849STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF2Cleared 510(K)
- K905850STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED2Cleared 510(K)
- K905852STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED2Cleared 510(K)
- K905840STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED2Cleared 510(K)
- K905841STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED2Cleared 510(K)
- K905842STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIED2Cleared 510(K)
- K905843STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF2Cleared 510(K)
- K911355LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 70152Cleared 510(K)
- K905848LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI2Cleared 510(K)
- K905846STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION2Cleared 510(K)
- K905851STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED2Cleared 510(K)
- K905847STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION2Cleared 510(K)
- K905844STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED2Cleared 510(K)
- K905646OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY2Cleared 510(K)
- K910005VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K904417CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM2Cleared 510(K)
- K903364GERARD MEDICAL, INC. TRIM-PORT2Cleared 510(K)
- K904077VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K903691A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.2Cleared 510(K)
- K903220PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM2Cleared 510(K)
- K901419DUAL PORT2Cleared 510(K)
- K901722CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM2Cleared 510(K)
- K895030LIFE-LINE(TM) VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K894650Q-PORT SYSTEM KIT2Cleared 510(K)
- K895689LIFEPORT VASCULAR ACCESS PORT2Cleared 510(K)
- K896093A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT2Cleared 510(K)
- K895871LIFEPORT POLYURETHANE CATHETER2Cleared 510(K)
- K893460A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM2Cleared 510(K)
- K891611MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.2Cleared 510(K)
- K890518SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K881342IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM2Cleared 510(K)
- K882230A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED2Cleared 510(K)
- K882190S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K881075LIFEPORT II, MODEL LPS-11002Cleared 510(K)
- K881745INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER2Cleared 510(K)
- K880305LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.2Cleared 510(K)
- K881256NON CORING INFUSION SET2Cleared 510(K)
- K875276PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM2Cleared 510(K)
- K880571CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K875213SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE2Cleared 510(K)
- K880297SEA - PORT INFUSION SET2Cleared 510(K)
- K875214A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K874184CHEMO-PORT2Cleared 510(K)
- K873575UNIPORT MODELS SD-90, TD-60, TD-70 & TD-902Cleared 510(K)
- K872329INFUSE-A-PORT ADDITIONAL SIZES2Cleared 510(K)
- K873735MEDTRONIC CATHETER ACCESS PORT MODEL 85002Cleared 510(K)
- K873213HICKMAN PLASTIC SUBCUTANEOUS PORT2Cleared 510(K)
- K872898POLYURETHANE CATHETER FOR THE INFUSE-A-PORT2Cleared 510(K)
- K872838NORFOLK NORPORT (TM) -SP (SKIN PARALLEL)2Cleared 510(K)
- K872149SURECATH-ITP PERCUTANEOUS ACCESS KIT2Cleared 510(K)
- K870950UNIPORT MODEL SD-60, SD-702Cleared 510(K)
- K870817MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT2Cleared 510(K)
- K871209NORFOLK MEDICAL NORPORT2Cleared 510(K)
- K871192SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT2Cleared 510(K)
- K870187NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT2Cleared 510(K)
- K870886LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER2Cleared 510(K)
- K870519SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT2Cleared 510(K)
- K870260HICKMAN TITANIUM SUBCUTANEOUS PORT2Cleared 510(K)
- K864446PORT-A-CATH VASCULAR ACCESS SYSTEMS2Cleared 510(K)
- K864349MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT2Cleared 510(K)
- K863750HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER2Cleared 510(K)
- K853827LIFE-PORT IMPLANTABLE VASCULAR ACCESS2Cleared 510(K)
- K863723NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT2Cleared 510(K)
- K863305HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER2Cleared 510(K)
- K863296INFUSE-A-PORT EXPLANT KIT2Cleared 510(K)
- K862018MICRO PORT2Cleared 510(K)
- K853332HDC CHEMO-PORT (VASCULAR)2Cleared 510(K)
- K861498MEDTRONIC MODEL 8501 ACCESS PORT2Cleared 510(K)
- K851293IMPLANTOFIX2Cleared 510(K)
- K853981INFUSAID INFUSE-A-PORT (MODIFIED)2Cleared 510(K)
- K854019PORT-GARD2Cleared 510(K)
- K853322MEDTRONIC ACCESS PORT MODEL 85002Cleared 510(K)
- K850967STERILE CORMED MEDIPORT2Cleared 510(K)
- K850888PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV2Cleared 510(K)
- K840481INFUSE-A-PORT HEPARIN LOCK MAINT KIT2Cleared 510(K)
- K842355INFUSAID INFUSE-A-PORT2Cleared 510(K)
- K841679VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD2Cleared 510(K)
- K841150VASCULAR-ACCESS PORT CHANGE CATHETER2Cleared 510(K)
- K840788VASCULAR ACCESS PORT CHANGES IN MATER2Cleared 510(K)
- K841149VASCULAR-ACCESS PORT - ENLARGEMENT2Cleared 510(K)
- K832917PORT-A-CATH2Cleared 510(K)
- K832788INFUSE-A-PORT2Cleared 510(K)
- K830730PORT-A-CATH IMPLANTABLE CATH. SYS2Cleared 510(K)
- K830000VASCULAR-ACCESS-PORT2Cleared 510(K)
- K823838INFUSE-A-PORT2Cleared 510(K)
- 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
PORTSMART NEEDLE DE-ACCESS ENCLOSURE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K964559
- 510(k) Type
- Traditional
- Applicant
- JIREH, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/3/1997
- Days to Decision
- 51 days
- Submission Type
- Statement