FDA 510(k) Applications for Medical Device Product Code "DTZ"
(Oxygenator, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K895393 3M COMPANY SARNS INGANT MEMBRANE OXYGENATOR 12/04/1989
K895632 3M COMPANY SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380 12/12/1989
K890808 3M COMPANY SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV 05/01/1989
K896671 3M COMPANY SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461 02/14/1990
K912920 3M HEALTH CARE, LTD. SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER 09/25/1991
K863515 3M HEALTH CARE, SARNS MODIFIED SARNS OXYGENATOR SYSTEM 11/18/1986
K911227 3M HEALTH CARE, SARNS NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS 05/29/1991
K903436 3M HEALTH CARE, SARNS SARNS MEMBRANE OXGENATOR PART NUMBER 9443 10/19/1990
K860539 3M HEALTH CARE, SARNS SARNS OXYGENATOR SYSTEM 04/29/1986
K912078 3M HEALTH CARE, SARNS SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION 08/20/1991
K912079 3M HEALTH CARE, SARNS SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY 10/23/1991
K925076 3M HEALTH CARE, SARNS SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R. 06/07/1993
K925075 3M HEALTH CARE, SARNS SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR 06/07/1993
K941653 3M HEALTH CARE, SARNS SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION 08/24/1994
K844901 AMERICAN BENTLEY AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH 03/07/1985
K851035 AMERICAN BENTLEY AMERICAN BENTLEY OXYGENATOR MAX-2 05/16/1985
K833518 AMERICAN BENTLEY BLOOD OXYGENATOR HEAT EXHANGER COATING 12/29/1983
K850630 AMERICAN BENTLEY BLOOD OXYGENATOR MODEL NO. MAX-5 03/27/1985
K833670 AMERICAN BENTLEY BOS-CM40,50 HOLDER & RESERVOIR BAG 01/03/1984
K830327 AMERICAN BENTLEY DOSIMETRIC RELEASE OF RADIATION DEV 03/24/1983
K861641 AMERICAN BENTLEY HEPARIN-COATED EXTRACORPOREAL CIRCUITS 09/29/1986
K873923 AMERICAN BENTLEY INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER 11/06/1987
K854045 AMERICAN BENTLEY MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED 12/16/1985
K872133 AMERICAN BENTLEY OXYGENATOR MODEL NO. BENTLEY 5 PLUS 08/24/1987
K863249 AMERICAN BENTLEY OXYGENATOR MODEL NO. BENTLEY-10 PLUS 10/20/1986
K860673 AMERICAN BENTLEY OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B 06/26/1986
K841476 AMERICAN BENTLEY TUBULAR HOLLOW FIBER MEMBRANE 08/03/1984
K811004 AMERICAN PHARMASEAL DIV. AHSC MANIFOLD 05/08/1981
K130520 ASHITAKA FACTORY OF TERUMO CORP. CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR 03/13/2013
K932252 AVECOR CARDIOVASCULAR, INC. AFFINITY HOLLOW FIBER OXYGENATOR 11/19/1993
K973760 AVECOR CARDIOVASCULAR, INC. AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE 02/18/1998
K892641 BARD CARDIOSURGERY DIV BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES 11/01/1989
K892664 BARD CARDIOSURGERY DIV CARDIOPULMONARY SUPPORT (CPS) SYSTEM 02/13/1990
K882892 BAXTER BENTLEY LABORATORIES, INC. MEMBRANE OXYGENATOR 09/27/1988
K910107 BAXTER HEALTHCARE CORP. DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD 04/10/1991
K951247 BAXTER HEALTHCARE CORP. SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS 11/02/1995
K941225 BAXTER HEALTHCARE CORP. UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT 08/16/1994
K894826 BENTLEY LABORATORIES, INC. "UNIVOX" W/HOLDERS, MODELS "UNIVOX-HL, HLB, HLF" 02/28/1990
K822803 BENTLEY LABORATORIES, INC. BLOOD OXYGENATORS #BOS-105S BOS-5S W/ 11/01/1982
K823273 BENTLEY LABORATORIES, INC. BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. 01/05/1983
K801240 BENTLEY LABORATORIES, INC. BUILT-IN TEMPERATURE MONITORING 06/04/1980
K874841 BENTLEY LABORATORIES, INC. INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER 02/02/1988
K781842 BENTLEY LABORATORIES, INC. OXYGENATOR, BLOOD BOS-10 11/08/1978
K780078 BENTLEY LABORATORIES, INC. OXYGENATOR, BUBBLE TYPE 09/14/1978
K823456 BENTLEY LABORATORIES, INC. OXYGENATORS #BOS-10, 105, 5S 12/30/1982
K802719 BENTLEY LABORATORIES, INC. SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S 12/16/1980
K802720 BENTLEY LABORATORIES, INC. SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S 12/16/1980
K901253 BIO MEDICUS, INC. (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 09/05/1990
K954850 C.R. BARD, INC. BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR 10/30/1996
K864235 C.R. BARD, INC. BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600 01/02/1987
K792039 C.R. BARD, INC. WILLIAM HARVEY H-1500 BLOOD OXYGENATOR 10/30/1979
K831122 C.R. BARD, INC. WILLIAM HARVEY H-1700 ADULT BLOOD OXYG- 05/25/1983
K853080 C.R. BARD, INC. WILLIAM HARVEY HYBID OXYGENATOR H-1700 10/11/1985
K821477 C.R. BARD, INC. WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD 11/01/1982
K831705 C.R. BARD, INC. WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD 07/18/1983
K153295 CARDIAC ASSIST, INC. TandemLung Oxygenator 02/26/2016
K800555 CARDIOVASCULAR RESEARCH, INC. PARTNER SEVEN DISP. BUBBLE OXYGENATOR 04/04/1980
K926467 COBE CARDIOVASCULAR, INC. COBE CMS-FS MEMBRANE OXYGENATOR 11/09/1993
K964043 COBE CARDIOVASCULAR, INC. COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS 09/29/1997
K963518 COBE CARDIOVASCULAR, INC. COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR 12/08/1997
K991452 COBE CARDIOVASCULAR, INC. COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR 10/07/1999
K974085 COBE CARDIOVASCULAR, INC. COBE OXYGENATOR PRODUCTS 01/27/1998
K000255 COBE CARDIOVASCULAR, INC. COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR 04/25/2000
K013480 COBE CARDIOVASCULAR, INC. COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR 11/16/2001
K974812 COBE CARDIOVASCULAR, INC. COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR 06/01/1998
K772284 COBE LABORATORIES, INC. BUBBLE-TYPE OXYGENATOR 02/02/1978
K810505 COBE LABORATORIES, INC. CARDIOPULMONARY BYPASS OXYGENATOR 04/23/1981
K880021 COBE LABORATORIES, INC. COBE CML3 04/01/1988
K923272 COBE LABORATORIES, INC. COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR 05/11/1993
K790356 COBE LABORATORIES, INC. OXYGENATOR, COBE CATALOG #42-220 03/09/1979
K842908 COBE LABORATORIES, INC. VARIABLE PRIME COBE MEMBRANE LUNG 02/01/1985
K833078 CORDIS CORP. HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000 01/27/1984
K790406 DELTA MEDICAL INDUSTRIES DELTA D-750 THERMAFLOW 11/13/1979
K010478 DIDECO DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR 09/27/2001
K004001 DIDECO MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR 10/04/2001
K014080 DIDECO S.P.A. APEX ADULT HOLLOWE FIBER OXYGENATOR 01/08/2002
K020997 DIDECO S.P.A. APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR 04/04/2002
K020351 DIDECO S.P.A. D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR 02/26/2002
K033323 DIDECO S.P.A. D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING 01/13/2004
K013915 DIDECO S.P.A. D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER 12/27/2001
K022450 DIDECO S.P.A. INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY 10/22/2002
K971877 DIDECO S.P.A. LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR 10/08/1997
K001021 DIDECO S.P.A. LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 04/25/2000
K991737 DIDECO S.P.A. LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR 02/17/2000
K031223 DIDECO S.P.A. SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR 05/02/2003
K043323 DIDECO S.R.L. D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR 02/01/2005
K953835 DIDECO S.R.L. LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR 03/15/1996
K050447 DIDECO S.R.L. PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR 03/08/2005
K830639 ELECTROMEDICS, INC. HI FLEX D-700 MODULAR BUBBLE OXYGENA- 05/25/1983
K141492 EUROSETS S.R.L. ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) 02/06/2015
K102109 EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 02/15/2011
K843955 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR 11/29/1984
K803003 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. INTERPULSE MEMBRANE OXYGENATION SYSTEM 01/22/1981
K821216 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. INTERPULSE MEMBRANE OXYGENATOR 06/02/1982
K823343 GAMBRO, INC. OXYGENATOR 10 12/15/1982
K961530 GISH BIOMEDICAL, INC. GISH RELIANCE OXYGENATOR (MODEL HFO) 12/05/1996
K090449 GISH BIOMEDICAL, INC. MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT 09/18/2009
K082403 GISH BIOMEDICAL, INC. MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT 05/15/2009
K090450 GISH BIOMEDICAL, INC. MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT 09/18/2009
K023381 GISH BIOMEDICAL, INC. VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING 03/31/2003
K080708 GISH BIOMEDICAL, INC. VISION HOLLOW FIBER OXYGENATOR WITH HA COATING 02/02/2009
K031903 GUIDANT CORPORATION RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 03/03/2004
K853251 JOHNSON & JOHNSON PROFESSIONALS, INC. J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO 10/16/1985
K030264 JOSTRA AG QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 02/26/2003
K992559 JOSTRA BENTLEY HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 09/20/1999
K071774 MAQUET CARDIOPULMONARY AG JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 01/23/2008
K061628 MAQUET CARDIOPULMONARY AG JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 08/22/2006
K090511 MAQUET CARDIOPULMONARY AG QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 06/12/2009
K082117 MAQUET CARDIOPULMONARY AG QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 02/18/2009
K150267 MAQUET CARDIOPULMONARY AG QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators 05/07/2015
K112360 MAQUET CARDIOPULMONARY AG QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES 09/15/2011
K102464 MAQUET CARDIOPULMONARY AG QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING 03/04/2011
K103191 MAQUET CARDIOPULMONARY AG QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING 03/08/2011
K093522 MAQUET CARDIOPULMONARY AG QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C 12/07/2009
K090689 MAQUET CARDIOPULMONARY AG QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 10/29/2009
K132829 MAQUET CARDIOPULMONARY AG QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS 10/08/2013
K101153 MAQUET CARDIOPULMONARY AG QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD 12/08/2010
K100278 MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA 04/30/2010
K133261 MEDOS MEDIZINTECHNIK AG MEDOS HILITE 7000 & 7000 LT OXYGENATOR 01/09/2014
K140181 MEDOS MEDIZINTECHNIK AG MEDOS HILITE INFANT OXYGENATOR 02/19/2014
K140177 MEDOS MEDIZINTECHNIK AG MEDOS HILITE OXYGENATOR 02/18/2014
K893207 MEDTRONIC BLOOD SYSTEMS, INC. CLOSED CHEST SUPPORT CIRCUIT 12/12/1989
K891687 MEDTRONIC BLOOD SYSTEMS, INC. EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE 05/31/1989
K891230 MEDTRONIC BLOOD SYSTEMS, INC. MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. 05/19/1989
K122827 MEDTRONIC INC. AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 12/14/2012
K123314 MEDTRONIC INC. AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE 01/22/2013
K100645 MEDTRONIC INC. AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE 09/14/2012
K992910 MEDTRONIC VASCULAR AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) 09/15/1999
K000430 MEDTRONIC VASCULAR AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 02/25/2000
K896978 MEDTRONIC VASCULAR CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE 02/28/1990
K926226 MEDTRONIC VASCULAR INTERSEPT FILTERED CARDIOTOMY RESERVOIR 06/22/1993
K962641 MEDTRONIC VASCULAR MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER 12/16/1996
K925626 MEDTRONIC VASCULAR MAXIMA PLUS HOLLOW FIBER OXYGENATOR 02/05/1993
K941473 MEDTRONIC VASCULAR MAXIMA PLUS HOLLOW FIBER OXYGENATOR 06/21/1995
K897068 MEDTRONIC VASCULAR MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR 08/28/1991
K912655 MEDTRONIC VASCULAR MINIMAX OXYGENATION SYSTEM 09/13/1991
K933586 MEDTRONIC VASCULAR MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE 02/07/1994
K920889 MEDTRONIC VASCULAR MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS 09/15/1992
K984271 MEDTRONIC VASCULAR MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0 03/09/1999
K142784 Medtronic, Inc Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface 10/24/2014
K172626 Medtronic, Inc. Affinity 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 & Cardiot 10/25/2017
K162016 MEDTRONIC, INC. Affinity NT Oxygenator with Cortiva BioActive Surface 09/21/2016
K162896 MEDTRONIC, INC. Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface 12/06/2016
K143073 Medtronic, Inc. Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface 03/25/2015
K172984 Medtronic, Inc. Affinity 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 11/20/2017
K964967 MINNTECH CORP. BIOCOR 200 HIGH PERFORMANCEOXYGENATOR 03/06/1997
K894970 MINNTECH CORP. WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR 11/01/1989
K934292 MINNTECH CORP. WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR 07/26/1994
K872107 MINNTECH CORP. WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR 08/28/1987
K782095 NAMIC STOPCOCKS, MANIFOLDS 01/23/1979
K072362 NOVALUNG GMBH NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG 10/23/2007
K912082 POLYSTAN A/S SAFE II 12/04/1991
K013038 POLYSTAN A/S SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 08/14/2002
K953976 POLYSTAN A/S SAFE MICRO 02/04/1997
K980974 POLYSTAN A/S SAFE MINI 10/13/2000
K893704 POLYSTAN C/O VITALCOR, INC. SAFE-1 12/22/1989
K843956 SCIMED LIFE SYSTEMS, INC. SCIMED II MEMBRANE OXYGENATOR SYSTEM 01/08/1985
K862918 SCIMED LIFE SYSTEMS, INC. SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM 09/23/1986
K863476 SCIMED LIFE SYSTEMS, INC. SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO 11/25/1986
K883053 SCIMED LIFE SYSTEMS, INC. SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A 09/26/1988
K883054 SCIMED LIFE SYSTEMS, INC. SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II 09/26/1988
K894103 SCIMED LIFE SYSTEMS, INC. SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II 09/21/1989
K023745 SECHRIST INDUSTRIES, INC. SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G 01/17/2003
K831895 SHILEY, INC. BLOOD OXYGENATOR 50 70/S 10/19/1983
K831894 SHILEY, INC. BLOOD OXYGENATOR 5070 10/20/1983
K781223 SHILEY, INC. OXYGENATOR, BLOOD, INFANT/PEDIATRIC 07/27/1978
K772237 SHILEY, INC. OXYGENATOR, BUBBLE 12/13/1977
K901250 SHILEY, INC. PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR 06/11/1990
K901249 SHILEY, INC. PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR 06/11/1990
K833253 SHILEY, INC. SHILEY M2000 MEMBRANE OXYGENATOR 12/01/1983
K901624 SHILEY, INC. SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. 07/03/1990
K894630 SHILEY, INC. SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR 10/20/1989
K810470 SHILEY, INC. SHILEY S-100A (ADULT) BLOOD OXYGENATOR 04/17/1981
K931444 SORIN BIOMEDICA, FIAT, USA, INC. PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS 05/27/1994
K922933 SORIN BIOMEDICA, FIAT, USA, INC. SORIN MONOLYRH INTEGRATED MEMBRANE LUNG 11/30/1992
K990103 SORIN BIOMEDICAL, INC. MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE 11/05/1999
K180448 Sorin Group Italia S.r.l INSPIRE 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 Filter 03/15/2018
K092895 SORIN GROUP ITALIA S.R.L. APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR 10/19/2009
K083021 SORIN GROUP ITALIA S.R.L. APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR 10/29/2008
K061031 SORIN GROUP ITALIA S.R.L. D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W 06/02/2006
K072091 SORIN GROUP ITALIA S.R.L. D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR 10/29/2007
K150489 SORIN GROUP ITALIA S.R.L. EOS PMP, EOS PMP Integrated 06/11/2015
K121909 SORIN GROUP ITALIA S.R.L. INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR 07/26/2012
K130209 SORIN GROUP ITALIA S.R.L. INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED 02/12/2013
K113626 SORIN GROUP ITALIA S.R.L. INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR 04/05/2012
K120185 SORIN GROUP ITALIA S.R.L. INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR 05/11/2012
K121229 SORIN GROUP ITALIA S.R.L. INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY 07/23/2012
K130433 SORIN GROUP ITALIA S.R.L. INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE 03/20/2013
K122254 SORIN GROUP ITALIA S.R.L. INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR 08/24/2012
K122844 SORIN GROUP ITALIA S.R.L. INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR 10/17/2012
K121536 SORIN GROUP ITALIA S.R.L. INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR 08/22/2012
K151713 SORIN GROUP ITALIA S.R.L. LILLIPUP PMP, LILLIPUT PMP INTEGRATED 11/06/2015
K073380 SORIN GROUP ITALIA S.R.L. SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI 02/29/2008
K802328 STANCO MEDICAL, INC. DISP. TOUGY-BORST TYPE ADAPTOR W/PORT 10/10/1980
K802970 TERUMO AMERICA, INC. TERUMO HOLLOW FIBER OXYGENATOR 01/22/1981
K062381 TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR 08/24/2006
K051997 TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR 09/15/2005
K010443 TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING 12/11/2001
K130359 TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA 03/13/2013
K130333 TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR 03/13/2013
K153140 TERUMO CARDIOVASCULAR SYSTEMS CORP. Terumo 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 Xcoating 12/02/2015
K153213 Terumo Cardiovascular Systems Corporation Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir 12/03/2015
K151389 Terumo Cardiovascular Systems Corporation Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir 10/20/2015
K151791 TERUMO CARDIOVASCULAR SYSTEMS CORPORATION Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir 11/19/2015
K140774 Terumo Cardiovascular Systems Corporation TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR 06/02/2014
K172071 Terumo Cardiovascular Systems Corporation Terumo 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) 03/29/2018
K180950 Terumo Cardiovascular Systems Corporation Terumo 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) 06/22/2018
K071572 TERUMO CORP. CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER 07/23/2007
K071494 TERUMO CORP. CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER 07/16/2007
K022115 TERUMO CORP. CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR 09/27/2002
K040210 TERUMO CORP. CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR 03/03/2004
K130280 TERUMO Corporation CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR 03/13/2013
K130493 TERUMO Corporation CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR 03/13/2013
K961734 TERUMO MEDICAL CORP. CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE 07/07/1997
K970463 TERUMO MEDICAL CORP. CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR 05/06/1997
K823125 TERUMO MEDICAL CORP. CAPIOX II 11/24/1982
K861177 TERUMO MEDICAL CORP. CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR 05/28/1986
K922799 TERUMO MEDICAL CORP. CAPIOX SX HOLLOW FIBER OXYGENATOR 09/02/1993
K960074 TERUMO MEDICAL CORP. CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR 10/16/1996
K961000 TERUMO MEDICAL CORP. CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR 10/02/1996
K962667 TERUMO MEDICAL CORP. CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR 10/07/1996
K812660 TERUMO MEDICAL CORP. TERUMO HOLLOW FIBER OXYGENATOR 12/14/1981
K993772 TERUMO MEDICAL CORP. X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR 06/05/2000
K810532 TEXAS MEDICAL PRODUCTS, INC. DISPOSABLE STOPCOCK 04/23/1981
K813255 TRAVENOL LABORATORIES, S.A. LPM/50 MEMBRANE OXYGENATOR 01/18/1982
K803231 TRAVENOL LABORATORIES, S.A. THB 6000 HARDSHELL BUBBLE OXYGENATOR 01/16/1981
K760824 TRAVENOL LABORATORIES, S.A. TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I 11/12/1976


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