FDA 510(k) Applications for Medical Device Product Code "DTZ"
(Oxygenator, Cardiopulmonary Bypass)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K222297 | Abbott | CentriMag Pre-connected Pack | 12/01/2022 |
| K200109 | Abiomed Inc. | OXY-1 System | 10/23/2020 |
| K223161 | Abiomed Inc. | OXY-1 System | 02/23/2023 |
| K130520 | ASHITAKA FACTORY OF TERUMO CORP. | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR | 03/13/2013 |
| K973760 | AVECOR CARDIOVASCULAR, INC. | AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE | 02/18/1998 |
| K954850 | C.R. BARD, INC. | BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR | 10/30/1996 |
| K153295 | CARDIAC ASSIST, INC. | TandemLung Oxygenator | 02/26/2016 |
| K191246 | Chalice Medical Ltd | Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) | 02/28/2020 |
| K201642 | Chalice Medical Ltd | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | 09/18/2020 |
| 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 |
| 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 |
| 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 |
| K202510 | Eurosets S.r.l. | AMG PMP Infant | 12/10/2021 |
| K202206 | Eurosets S.r.l. | AMG PMP Pediatric | 04/01/2021 |
| 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 |
| 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 |
| K203111 | Medtronic | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | 09/16/2021 |
| K183490 | Medtronic Inc | Affinity 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 Biosurface | 04/12/2019 |
| K183511 | Medtronic Inc | Affinity PixieÖ Oxygenator with BalanceÖ Biosurface (Model BBP211), Affinity PixieÖ Oxygenator and Cardiotomy/Venous Reservoir with BalanceÖ Biosurface (Model BBP241), Affinity PixieÖ Oxygenator with CortivaÖ BioActive Surface (Model CBP211), Affinity Pix | 03/18/2019 |
| 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 |
| K230640 | Medtronic Inc. | Affinity FusionÖ Oxygenator System | 04/06/2023 |
| 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 |
| K962641 | MEDTRONIC VASCULAR | MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER | 12/16/1996 |
| 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 |
| K191444 | Medtronic, Inc. | Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir | 09/27/2019 |
| 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 |
| K191029 | Medtronic, Inc. | Affinity 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 Int | 05/17/2019 |
| 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 |
| K072362 | NOVALUNG GMBH | NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG | 10/23/2007 |
| 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 |
| K203424 | Qura S.r.l. | Quantum 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-E2 | 12/17/2021 |
| K212341 | Qura S.r.l. | 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-C1U,Quantum Perfusion Blood Oxygenator with | 01/28/2022 |
| 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 |
| K211495 | Sorin Group Italia S.R.L | EOS PMP | 07/12/2021 |
| K201916 | Sorin Group Italia S.r.l | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator | 08/13/2020 |
| 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 |
| K190690 | SORIN GROUP ITALIA S.R.L. | INSPIRE 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 Reservoir | 04/13/2019 |
| K200683 | Sorin Group Italia S.R.L. | INSPIRE 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 reservoi | 06/12/2020 |
| 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 |
| 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 |
| 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 |
| K993772 | TERUMO MEDICAL CORP. | X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR | 06/05/2000 |
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