Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- BYSOxygenator, Long Term Support Greater Than 6 Hours2Product Code
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2Product Code
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2Product Code
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line2Product Code
- DTNReservoir, Blood, Cardiopulmonary Bypass2Product Code
- DTPDefoamer, Cardiopulmonary Bypass2Product Code
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2Product Code
- DTRHeat-Exchanger, Cardiopulmonary Bypass2Product Code
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass2Product Code
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass2Product Code
- DTXGas Control Unit, Cardiopulmonary Bypass2Product Code
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass2Product Code
- DTZOxygenator, Cardiopulmonary Bypass2Product Code
- K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E22Cleared 510(K)
- K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)2Cleared 510(K)
- K241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)2Cleared 510(K)
- K231652D100 KIDS; D101 KIDS2Cleared 510(K)
- K231773Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U2Cleared 510(K)
- K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)2Cleared 510(K)
- K230640Affinity Fusion™ Oxygenator System2Cleared 510(K)
- K223161OXY-1 System2Cleared 510(K)
- K222297CentriMag Pre-connected Pack2Cleared 510(K)
- K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U2Cleared 510(K)
- K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E22Cleared 510(K)
- K202510AMG PMP Infant2Cleared 510(K)
- K203111Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System2Cleared 510(K)
- K211495EOS PMP2Cleared 510(K)
- K202206AMG PMP Pediatric2Cleared 510(K)
- K200109OXY-1 System2Cleared 510(K)
- K201642Paragon Adult Maxi PMP Oxygenator with Tubing Pack2Cleared 510(K)
- K201916Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator2Cleared 510(K)
- K200683INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir2Cleared 510(K)
- K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)2Cleared 510(K)
- K191444Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir2Cleared 510(K)
- K191029Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac2Cleared 510(K)
- K190690INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir2Cleared 510(K)
- K183490Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface2Cleared 510(K)
- K183511Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241)2Cleared 510(K)
- K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)2Cleared 510(K)
- K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)2Cleared 510(K)
- K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter2Cleared 510(K)
- K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface2Cleared 510(K)
- K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir2Cleared 510(K)
- K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface2Cleared 510(K)
- K162016Affinity NT Oxygenator with Cortiva BioActive Surface2Cleared 510(K)
- K153295TandemLung Oxygenator2Cleared 510(K)
- K153213Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir2Cleared 510(K)
- K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating2Cleared 510(K)
- K151791Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir2Cleared 510(K)
- K151713LILLIPUP PMP, LILLIPUT PMP INTEGRATED2Cleared 510(K)
- K151389Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir2Cleared 510(K)
- K150489EOS PMP, EOS PMP Integrated2Cleared 510(K)
- K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators2Cleared 510(K)
- K143073Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface2Cleared 510(K)
- K141492ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)2Cleared 510(K)
- K142784Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface2Cleared 510(K)
- K140774TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR2Cleared 510(K)
- K140181MEDOS HILITE INFANT OXYGENATOR2Cleared 510(K)
- K140177MEDOS HILITE OXYGENATOR2Cleared 510(K)
- K133261MEDOS HILITE 7000 & 7000 LT OXYGENATOR2Cleared 510(K)
- K132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS2Cleared 510(K)
- K130433INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE2Cleared 510(K)
- K130520CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR2Cleared 510(K)
- K130493CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR2Cleared 510(K)
- K130359CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA2Cleared 510(K)
- K130333CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR2Cleared 510(K)
- K130280CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR2Cleared 510(K)
- K130209INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED2Cleared 510(K)
- K123314AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE2Cleared 510(K)
- K122827AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB8112Cleared 510(K)
- K122844INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR2Cleared 510(K)
- K100645AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE2Cleared 510(K)
- K122254INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR2Cleared 510(K)
- K121536INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR2Cleared 510(K)
- K121909INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR2Cleared 510(K)
- K121229INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY2Cleared 510(K)
- K120185INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR2Cleared 510(K)
- K113626INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR2Cleared 510(K)
- K112360QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES2Cleared 510(K)
- K103191QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING2Cleared 510(K)
- K102464QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING2Cleared 510(K)
- K102109ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU50122Cleared 510(K)
- K101153QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD2Cleared 510(K)
- K100278QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA2Cleared 510(K)
- K093522QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C2Cleared 510(K)
- K090689QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 510002Cleared 510(K)
- K092895APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR2Cleared 510(K)
- K090449MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT2Cleared 510(K)
- K090450MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT2Cleared 510(K)
- K090511QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO700002Cleared 510(K)
- K082403MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT2Cleared 510(K)
- K082117QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 710002Cleared 510(K)
- K080708VISION HOLLOW FIBER OXYGENATOR WITH HA COATING2Cleared 510(K)
- K083021APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR2Cleared 510(K)
- K073380SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI2Cleared 510(K)
- K071774JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 20302Cleared 510(K)
- K072091D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR2Cleared 510(K)
- K072362NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG2Cleared 510(K)
- K071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER2Cleared 510(K)
- K071494CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER2Cleared 510(K)
- K062381CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR2Cleared 510(K)
- K061628JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 20302Cleared 510(K)
- K061031D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W2Cleared 510(K)
- K051997CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR2Cleared 510(K)
- K050447PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR2Cleared 510(K)
- K043323D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR2Cleared 510(K)
- K040210CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR2Cleared 510(K)
- K031903RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 75682Cleared 510(K)
- K033323D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING2Cleared 510(K)
- K031223SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR2Cleared 510(K)
- K023381VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING2Cleared 510(K)
- K030264QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 20302Cleared 510(K)
- K022450INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY2Cleared 510(K)
- K022115CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR2Cleared 510(K)
- K013038SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 0160102Cleared 510(K)
- K020997APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR2Cleared 510(K)
- K020351D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K014080APEX ADULT HOLLOWE FIBER OXYGENATOR2Cleared 510(K)
- K013915D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER2Cleared 510(K)
- K010443CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING2Cleared 510(K)
- K013480COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR2Cleared 510(K)
- K004001MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K010478DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR2Cleared 510(K)
- K980974SAFE MINI2Cleared 510(K)
- K993772X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR2Cleared 510(K)
- K001021LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D9022Cleared 510(K)
- K000255COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR2Cleared 510(K)
- K000430AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB5112Cleared 510(K)
- K991737LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K990103MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE2Cleared 510(K)
- K991452COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR2Cleared 510(K)
- K992559HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 10102Cleared 510(K)
- K992910AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)2Cleared 510(K)
- K984271MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M02Cleared 510(K)
- K974812COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR2Cleared 510(K)
- K973760AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE2Cleared 510(K)
- K974085COBE OXYGENATOR PRODUCTS2Cleared 510(K)
- K963518COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR2Cleared 510(K)
- K971877LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K964043COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS2Cleared 510(K)
- K961734CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE2Cleared 510(K)
- K970463CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR2Cleared 510(K)
- K964967BIOCOR 200 HIGH PERFORMANCEOXYGENATOR2Cleared 510(K)
- K953976SAFE MICRO2Cleared 510(K)
- K962641MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER2Cleared 510(K)
- K961530GISH RELIANCE OXYGENATOR (MODEL HFO)2Cleared 510(K)
- K954850BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR2Cleared 510(K)
- K960074CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR2Cleared 510(K)
- K962667CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR2Cleared 510(K)
- K961000CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR2Cleared 510(K)
- K953835LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K951247SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS2Cleared 510(K)
- K941473MAXIMA PLUS HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K941653SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION2Cleared 510(K)
- K941225UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT2Cleared 510(K)
- K934292WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR2Cleared 510(K)
- K931444PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS2Cleared 510(K)
- K933586MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE2Cleared 510(K)
- K932252AFFINITY HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K926467COBE CMS-FS MEMBRANE OXYGENATOR2Cleared 510(K)
- K922799CAPIOX SX HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K926226INTERSEPT FILTERED CARDIOTOMY RESERVOIR2Cleared 510(K)
- K925075SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR2Cleared 510(K)
- K925076SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.2Cleared 510(K)
- K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR2Cleared 510(K)
- K925626MAXIMA PLUS HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K922933SORIN MONOLYRH INTEGRATED MEMBRANE LUNG2Cleared 510(K)
- K920889MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS2Cleared 510(K)
- K912082SAFE II2Cleared 510(K)
- K912079SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY2Cleared 510(K)
- K912920SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER2Cleared 510(K)
- K912655MINIMAX OXYGENATION SYSTEM2Cleared 510(K)
- K897068MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K912078SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION2Cleared 510(K)
- K911227NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS2Cleared 510(K)
- K910107DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD2Cleared 510(K)
- K903436SARNS MEMBRANE OXGENATOR PART NUMBER 94432Cleared 510(K)
- K901253(PBS) PORTABLE BYPASS SYSTEM, MODEL 10002Cleared 510(K)
- K901624SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.2Cleared 510(K)
- K901249PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K901250PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K896978CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE2Cleared 510(K)
- K894826UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF2Cleared 510(K)
- K896671SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #94612Cleared 510(K)
- K892664CARDIOPULMONARY SUPPORT (CPS) SYSTEM2Cleared 510(K)
- K893704SAFE-12Cleared 510(K)
- K895632SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 163802Cleared 510(K)
- K893207CLOSED CHEST SUPPORT CIRCUIT2Cleared 510(K)
- K895393SARNS INGANT MEMBRANE OXYGENATOR2Cleared 510(K)
- K894970WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR2Cleared 510(K)
- K892641BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES2Cleared 510(K)
- K894630SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K894103SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II2Cleared 510(K)
- K891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE2Cleared 510(K)
- K891230MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.2Cleared 510(K)
- K890808SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV2Cleared 510(K)
- K882892MEMBRANE OXYGENATOR2Cleared 510(K)
- K883054SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II2Cleared 510(K)
- K883053SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A2Cleared 510(K)
- K880021COBE CML32Cleared 510(K)
- K874841INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER2Cleared 510(K)
- K873923INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER2Cleared 510(K)
- K872107WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR2Cleared 510(K)
- K872133OXYGENATOR MODEL NO. BENTLEY 5 PLUS2Cleared 510(K)
- K864235BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-16002Cleared 510(K)
- K863476SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO2Cleared 510(K)
- K863515MODIFIED SARNS OXYGENATOR SYSTEM2Cleared 510(K)
- K863249OXYGENATOR MODEL NO. BENTLEY-10 PLUS2Cleared 510(K)
- K861641HEPARIN-COATED EXTRACORPOREAL CIRCUITS2Cleared 510(K)
- K862918SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM2Cleared 510(K)
- K860673OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B2Cleared 510(K)
- K861177CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR2Cleared 510(K)
- K860539SARNS OXYGENATOR SYSTEM2Cleared 510(K)
- K854045MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED2Cleared 510(K)
- K853251J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO2Cleared 510(K)
- K853080WILLIAM HARVEY HYBID OXYGENATOR H-17002Cleared 510(K)
- K851035AMERICAN BENTLEY OXYGENATOR MAX-22Cleared 510(K)
- K850630BLOOD OXYGENATOR MODEL NO. MAX-52Cleared 510(K)
- K844901AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH2Cleared 510(K)
- K842908VARIABLE PRIME COBE MEMBRANE LUNG2Cleared 510(K)
- K843956SCIMED II MEMBRANE OXYGENATOR SYSTEM2Cleared 510(K)
- K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K841476TUBULAR HOLLOW FIBER MEMBRANE2Cleared 510(K)
- K833078HOLLOW FIBER MEMBRANE OXYGENATOR-HF40002Cleared 510(K)
- K833670BOS-CM40,50 HOLDER & RESERVOIR BAG2Cleared 510(K)
- K833518BLOOD OXYGENATOR HEAT EXHANGER COATING2Cleared 510(K)
- K833253SHILEY M2000 MEMBRANE OXYGENATOR2Cleared 510(K)
- K831894BLOOD OXYGENATOR 50702Cleared 510(K)
- K831895BLOOD OXYGENATOR 50 70/S2Cleared 510(K)
- K831705WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD2Cleared 510(K)
- K831122WILLIAM HARVEY H-1700 ADULT BLOOD OXYG-2Cleared 510(K)
- K830639HI FLEX D-700 MODULAR BUBBLE OXYGENA-2Cleared 510(K)
- K830327DOSIMETRIC RELEASE OF RADIATION DEV2Cleared 510(K)
- K823273BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.2Cleared 510(K)
- K823456OXYGENATORS #BOS-10, 105, 5S2Cleared 510(K)
- K823343OXYGENATOR 102Cleared 510(K)
- K823125CAPIOX II2Cleared 510(K)
- K822803BLOOD OXYGENATORS #BOS-105S BOS-5S W/2Cleared 510(K)
- K821477WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD2Cleared 510(K)
- K821216INTERPULSE MEMBRANE OXYGENATOR2Cleared 510(K)
- K813255LPM/50 MEMBRANE OXYGENATOR2Cleared 510(K)
- K812660TERUMO HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K811004MANIFOLD2Cleared 510(K)
- K810532DISPOSABLE STOPCOCK2Cleared 510(K)
- K810505CARDIOPULMONARY BYPASS OXYGENATOR2Cleared 510(K)
- K810470SHILEY S-100A (ADULT) BLOOD OXYGENATOR2Cleared 510(K)
- K803003INTERPULSE MEMBRANE OXYGENATION SYSTEM2Cleared 510(K)
- K802970TERUMO HOLLOW FIBER OXYGENATOR2Cleared 510(K)
- K803231THB 6000 HARDSHELL BUBBLE OXYGENATOR2Cleared 510(K)
- K802719SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S2Cleared 510(K)
- K802720SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S2Cleared 510(K)
- K802328DISP. TOUGY-BORST TYPE ADAPTOR W/PORT2Cleared 510(K)
- K801240BUILT-IN TEMPERATURE MONITORING2Cleared 510(K)
- K800555PARTNER SEVEN DISP. BUBBLE OXYGENATOR2Cleared 510(K)
- K790406DELTA D-750 THERMAFLOW2Cleared 510(K)
- K792039WILLIAM HARVEY H-1500 BLOOD OXYGENATOR2Cleared 510(K)
- K790356OXYGENATOR, COBE CATALOG #42-2202Cleared 510(K)
- K781842OXYGENATOR, BLOOD BOS-102Cleared 510(K)
- K780078OXYGENATOR, BUBBLE TYPE2Cleared 510(K)
- K781223OXYGENATOR, BLOOD, INFANT/PEDIATRIC2Cleared 510(K)
- K772284BUBBLE-TYPE OXYGENATOR2Cleared 510(K)
- K772237OXYGENATOR, BUBBLE2Cleared 510(K)
- K760824TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I2Cleared 510(K)
- DWAControl, Pump Speed, Cardiopulmonary Bypass2Product Code
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type2Product Code
- DWCController, Temperature, Cardiopulmonary Bypass2Product Code
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass2Product Code
- DWETubing, Pump, Cardiopulmonary Bypass2Product Code
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2Product Code
- DWPDilator, Vessel, Surgical2Product Code
- DWQStripper, Vein, External2Product Code
- DWSInstruments, Surgical, Cardiovascular1Product Code
- DWXStripper, Artery, Intraluminal2Product Code
- DWZDevice, Biopsy, Endomyocardial2Product Code
- DXCClamp, Vascular2Product Code
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass2Product Code
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass2Product Code
- JORGenerator, Pulsatile Flow, Cardiopulmonary Bypass3Product Code
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2Product Code
- KRIAccessory Equipment, Cardiopulmonary Bypass1Product Code
- KRJFilter, Prebypass, Cardiopulmonary Bypass2Product Code
- KRLDetector, Bubble, Cardiopulmonary Bypass2Product Code
- LXNProbe, Test, Heart-Valve1Product Code
- MCWCatheter, Peripheral, Atherectomy2Product Code
- MFYEndothelial Cell Harvesting Kit2Product Code
- MGZValvulotome2Product Code
- MJJCpb Check Valve, Retrograde Flow, In-Line2Product Code
- MJNCatheter, Intravascular Occluding, Temporary2Product Code
- MNJValve, Pressure Relief, Cardiopulmonary Bypass2Product Code
- MWSStabilizer, Heart1Product Code
- NCPCannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection2Product Code
- NLJStripper, Vein, External, Reprocessed2Product Code
- NMFClamp, Vascular, Reprocessed2Product Code
- NQGStabilizer, Heart, Non-Compression, Reprocessed1Product Code
- OETCardioplegia Solution Administration Kit2Product Code
- OEUCardiopulmonary Bypass Catheter Kit2Product Code
- OFACardiovascular Surgical Instruments Tray1Product Code
- OFGCt Biopsy Tray2Product Code
- PNQApical Closure Device2Product Code
- PYXTemporary Non-Roller Type Right Heart Support Blood Pump3Product Code
- PTNReservoir, Blood, Cardiopulmonary Bypass, Exempt2Product Code
- PZSDual Lumen Ecmo Cannula2Product Code
- QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure2Product Code
- QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use2Product Code
- QOHExtracorporeal System For Carbon Dioxide Removal2Product Code
- QHWSingle Lumen Ecmo Cannula2Product Code
- QTFReprocessed Atherectomy Catheter2Product Code
- QWFTubing, Long Term Support Greater Than 6 Hours2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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SAFE II
- Page Type
- Cleared 510(K)
- 510(k) Number
- K912082
- 510(k) Type
- Traditional
- Applicant
- POLYSTAN A/S
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/4/1991
- Days to Decision
- 208 days
- Submission Type
- Statement