Product Code: DTZ FDA class 2 21 CFR 870.4350

Oxygenator, Cardiopulmonary Bypass

Cardiovascular

The Cardiopulmonary Bypass Oxygenator is a life-sustaining cardiovascular device that assumes the function of the lungs during open-heart surgery by oxygenating venous blood and removing carbon dioxide as it passes through the extracorporeal circuit before being returned to the patient. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTZ and it is regulated under 21 CFR 870.4350 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

View on FDA

510(k)s

254

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DTZ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DTZ
Device Class: FDA class 2
Regulation Number: 870.4350
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 254 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253838	Lifemotion Disposable Membrane Oxygenator	Mar 16, 2026	Substantially Equivalent	Lifemotion Medical Technology Co., Ltd.
K240934	Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);	Mar 12, 2026	Substantially Equivalent	Spectrum Medical S.R.L.
K250821	Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)	Dec 12, 2025	Substantially Equivalent	Eurosets S.R.L
K242503	Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)	Nov 24, 2025	Substantially Equivalent	Eurosets S.R.L
K231982	Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2	Sep 12, 2024	Substantially Equivalent	Qura S.R.L
K240666	Affinity 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)	Jul 10, 2024	Substantially Equivalent	Medtronic Perfusion Systems
K241352	Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)	Jun 12, 2024	Substantially Equivalent	Medtronic, Inc.
K231652	D100 KIDS; D101 KIDS	Nov 16, 2023	Substantially Equivalent	Sorin Group Italia S.R.L.
K231773	Quantum 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-C1U	Nov 08, 2023	Substantially Equivalent	Qura S.R.L
K231414	CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)	Nov 01, 2023	Substantially Equivalent	Chalice Medical , Ltd.
K230640	Affinity Fusion Oxygenator System	Apr 06, 2023	Substantially Equivalent	Medtronic, Inc.
K223161	OXY-1 System	Feb 23, 2023	Substantially Equivalent	Abiomed, Inc.
K222297	CentriMag Pre-connected Pack	Dec 01, 2022	Substantially Equivalent	Abbott
K212341	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 Integrated AF VT160-C2U	Jan 28, 2022	Substantially Equivalent	Qura S.R.L
K203424	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	Dec 17, 2021	Substantially Equivalent	Qura S.R.L
K202510	AMG PMP Infant	Dec 10, 2021	Substantially Equivalent	Eurosets S.R.L
K203111	Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System	Sep 16, 2021	Substantially Equivalent	Medtronic
K211495	EOS PMP	Jul 12, 2021	Substantially Equivalent	Sorin Group Italia S.R.L.
K202206	AMG PMP Pediatric	Apr 01, 2021	Substantially Equivalent	Eurosets S.R.L
K200109	OXY-1 System	Oct 23, 2020	Substantially Equivalent	Abiomed, Inc.
K201642	Paragon Adult Maxi PMP Oxygenator with Tubing Pack	Sep 18, 2020	Substantially Equivalent	Chalice Medical , Ltd.
K201916	Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator	Aug 13, 2020	Substantially Equivalent	Sorin Group Italia S.R.L.
K200683	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 reservoir	Jun 12, 2020	Substantially Equivalent	Sorin Group Italia S.R.L.
K191246	Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)	Feb 28, 2020	Substantially Equivalent	Chalice Medical , Ltd.
K191444	Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir	Sep 27, 2019	Substantially Equivalent	Medtronic, Inc.
K191029	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 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® Biosurfac	May 17, 2019	Substantially Equivalent	Medtronic, Inc.
K190690	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	Apr 13, 2019	Substantially Equivalent	Sorin Group Italia S.R.L.
K183490	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	Apr 12, 2019	Substantially Equivalent	Medtronic, Inc.
K183511	Affinity 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)	Mar 18, 2019	Substantially Equivalent	Medtronic, Inc.
K180950	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)	Jun 22, 2018	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K172071	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)	Mar 29, 2018	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K180448	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	Mar 15, 2018	Substantially Equivalent	Sorin Group Italia S.R.L.
K172984	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 Cortiva BioActive Surface	Nov 20, 2017	Substantially Equivalent	Medtronic, Inc.
K172626	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 & Cardiotomy/Venous Reservoir	Oct 25, 2017	Substantially Equivalent	Medtronic, Inc.
K162896	Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface	Dec 06, 2016	Substantially Equivalent	Medtronic, Inc.
K162016	Affinity NT Oxygenator with Cortiva BioActive Surface	Sep 21, 2016	Substantially Equivalent	Medtronic, Inc.
K153295	TandemLung Oxygenator	Feb 26, 2016	Substantially Equivalent	Cardiacassist, Inc.
K153213	Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir	Dec 03, 2015	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K153140	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	Dec 02, 2015	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K151791	Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir	Nov 19, 2015	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K151713	LILLIPUP PMP, LILLIPUT PMP INTEGRATED	Nov 06, 2015	Substantially Equivalent	Sorin Group Italia S.R.L.
K151389	Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir	Oct 20, 2015	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K150489	EOS PMP, EOS PMP Integrated	Jun 11, 2015	Substantially Equivalent	Sorin Group Italia S.R.L.
K150267	QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators	May 07, 2015	Substantially Equivalent	Maquet Cardiopulmonary, AG
K143073	Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface	Mar 25, 2015	Substantially Equivalent	Medtronic, Inc.
K141492	ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)	Feb 06, 2015	Substantially Equivalent	Eurosets S.R.L
K142784	Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface	Oct 24, 2014	Substantially Equivalent	Medtronic, Inc.
K140774	TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR	Jun 02, 2014	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K140181	MEDOS HILITE INFANT OXYGENATOR	Feb 19, 2014	Substantially Equivalent	Medos Medizintechnik AG
K140177	MEDOS HILITE OXYGENATOR	Feb 18, 2014	Substantially Equivalent	Medos Medizintechnik AG
K133261	MEDOS HILITE 7000 & 7000 LT OXYGENATOR	Jan 09, 2014	Substantially Equivalent	Medos Medizintechnik AG
K132829	QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS	Oct 08, 2013	Substantially Equivalent	Maquet Cardiopulmonary, AG
K130433	INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE	Mar 20, 2013	Substantially Equivalent	Sorin Group Italia S.R.L.
K130520	CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR	Mar 13, 2013	Substantially Equivalent	Ashitaka Factory of Terumo Corp.
K130493	CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR	Mar 13, 2013	Substantially Equivalent	Terumo Corporation
K130359	CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA	Mar 13, 2013	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K130333	CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR	Mar 13, 2013	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K130280	CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR	Mar 13, 2013	Substantially Equivalent	Terumo Corporation
K130209	INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED	Feb 12, 2013	Substantially Equivalent	Sorin Group Italia S.R.L.
K123314	AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE	Jan 22, 2013	Substantially Equivalent	Medtronic, Inc.
K122827	AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811	Dec 14, 2012	Substantially Equivalent	Medtronic, Inc.
K122844	INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR	Oct 17, 2012	Substantially Equivalent	Sorin Group Italia S.R.L.
K100645	AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE	Sep 14, 2012	Substantially Equivalent	Medtronic, Inc.
K122254	INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR	Aug 24, 2012	Substantially Equivalent	Sorin Group Italia S.R.L.
K121536	INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR	Aug 22, 2012	Substantially Equivalent	Sorin Group Italia S.R.L.
K121909	INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR	Jul 26, 2012	Substantially Equivalent	Sorin Group Italia S.R.L.
K121229	INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY	Jul 23, 2012	Substantially Equivalent	Sorin Group Italia S.R.L.
K120185	INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR	May 11, 2012	Substantially Equivalent	Sorin Group Italia S.R.L.
K113626	INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR	Apr 05, 2012	Substantially Equivalent	Sorin Group Italia S.R.L.
K112360	QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES	Sep 15, 2011	Substantially Equivalent	Maquet Cardiopulmonary, AG
K103191	QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING	Mar 08, 2011	Substantially Equivalent	Maquet Cardiopulmonary, AG
K102464	QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING	Mar 04, 2011	Substantially Equivalent	Maquet Cardiopulmonary, AG
K102109	ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012	Feb 15, 2011	Substantially Equivalent	Eurosets S.R.L
K101153	QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD	Dec 08, 2010	Substantially Equivalent	Maquet Cardiopulmonary, AG
K100278	QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA	Apr 30, 2010	Substantially Equivalent	Maquet Cardiopulmonary, AG
K093522	QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C	Dec 07, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K090689	QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000	Oct 29, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K092895	APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR	Oct 19, 2009	Substantially Equivalent	Sorin Group Italia S.R.L.
K090450	MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT	Sep 18, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K090449	MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT	Sep 18, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K090511	QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000	Jun 12, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K082403	MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT	May 15, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K082117	QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000	Feb 18, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K080708	VISION HOLLOW FIBER OXYGENATOR WITH HA COATING	Feb 02, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K083021	APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR	Oct 29, 2008	Substantially Equivalent	Sorin Group Italia S.R.L.
K073380	SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI	Feb 29, 2008	Substantially Equivalent	Sorin Group Italia S.R.L.
K071774	JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030	Jan 23, 2008	Substantially Equivalent	Maquet Cardiopulmonary, AG
K072091	D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR	Oct 29, 2007	Substantially Equivalent	Sorin Group Italia S.R.L.
K072362	NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG	Oct 23, 2007	Substantially Equivalent	Novalung GmbH
K071572	CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER	Jul 23, 2007	Substantially Equivalent	Terumo Corp.
K071494	CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER	Jul 16, 2007	Substantially Equivalent	Terumo Corp.
K062381	CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR	Aug 24, 2006	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K061628	JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030	Aug 22, 2006	Substantially Equivalent	Maquet Cardiopulmonary, AG
K061031	D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W	Jun 02, 2006	Substantially Equivalent	Sorin Group Italia S.R.L.
K051997	CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR	Sep 15, 2005	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K050447	PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR	Mar 08, 2005	Substantially Equivalent	Dideco S.R.L.
K043323	D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR	Feb 01, 2005	Substantially Equivalent	Dideco S.R.L.
K040210	CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR	Mar 03, 2004	Substantially Equivalent	Terumo Corp.
K031903	RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568	Mar 03, 2004	Substantially Equivalent	Guidant Corporation
K033323	D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING	Jan 13, 2004	Substantially Equivalent	Dideco S.P.A.
K031223	SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR	May 02, 2003	Substantially Equivalent	Dideco S.P.A.
K023381	VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING	Mar 31, 2003	Substantially Equivalent	Gish Biomedical, Inc.
K030264	QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030	Feb 26, 2003	Substantially Equivalent	Jostra AG
K022450	INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY	Oct 22, 2002	Substantially Equivalent	Dideco S.P.A.
K022115	CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR	Sep 27, 2002	Substantially Equivalent	Terumo Corp.
K013038	SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010	Aug 14, 2002	Substantially Equivalent	Polystan A/S
K020997	APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR	Apr 04, 2002	Substantially Equivalent	Dideco S.P.A.
K020351	D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR	Feb 26, 2002	Substantially Equivalent	Dideco S.P.A.
K014080	APEX ADULT HOLLOWE FIBER OXYGENATOR	Jan 08, 2002	Substantially Equivalent	Dideco S.P.A.
K013915	D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER	Dec 27, 2001	Substantially Equivalent	Dideco S.P.A.
K010443	CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING	Dec 11, 2001	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K013480	COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR	Nov 16, 2001	Substantially Equivalent	Cobe Cardiovascular, Inc.
K004001	MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR	Oct 04, 2001	Substantially Equivalent	Dideco
K010478	DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR	Sep 27, 2001	Substantially Equivalent	Dideco
K980974	SAFE MINI	Oct 13, 2000	Substantially Equivalent	Polystan A/S
K993772	X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR	Jun 05, 2000	Substantially Equivalent	Terumo Medical Corp.
K001021	LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902	Apr 25, 2000	Substantially Equivalent	Dideco S.P.A.
K000255	COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR	Apr 25, 2000	Substantially Equivalent	Cobe Cardiovascular, Inc.
K000430	AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511	Feb 25, 2000	Substantially Equivalent	Medtronic Vascular
K991737	LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR	Feb 17, 2000	Substantially Equivalent	Dideco S.P.A.
K990103	MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE	Nov 05, 1999	Substantially Equivalent	Sorin Biomedical, Inc.
K991452	COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR	Oct 07, 1999	Substantially Equivalent	Cobe Cardiovascular, Inc.
K992559	HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010	Sep 20, 1999	Substantially Equivalent	Jostra Bentley
K992910	AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)	Sep 15, 1999	Substantially Equivalent	Medtronic Vascular
K984271	MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0	Mar 09, 1999	Substantially Equivalent	Medtronic Vascular
K974812	COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR	Jun 01, 1998	Substantially Equivalent	Cobe Cardiovascular, Inc.
K973760	AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE	Feb 18, 1998	Substantially Equivalent	Avecor Cardiovascular, Inc.
K974085	COBE OXYGENATOR PRODUCTS	Jan 27, 1998	Substantially Equivalent	Cobe Cardiovascular, Inc.
K963518	COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR	Dec 08, 1997	Substantially Equivalent	Cobe Cardiovascular, Inc.
K971877	LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR	Oct 08, 1997	Substantially Equivalent	Dideco S.P.A.
K964043	COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS	Sep 29, 1997	Substantially Equivalent	Cobe Cardiovascular, Inc.
K961734	CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE	Jul 07, 1997	Substantially Equivalent	Terumo Medical Corp.
K970463	CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR	May 06, 1997	Substantially Equivalent	Terumo Medical Corp.
K964967	BIOCOR 200 HIGH PERFORMANCEOXYGENATOR	Mar 06, 1997	Substantially Equivalent	Minntech Corp.
K953976	SAFE MICRO	Feb 04, 1997	Substantially Equivalent	Polystan A/S
K962641	MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER	Dec 16, 1996	Substantially Equivalent	Medtronic Vascular
K961530	GISH RELIANCE OXYGENATOR (MODEL HFO)	Dec 05, 1996	Substantially Equivalent	Gish Biomedical, Inc.
K954850	BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR	Oct 30, 1996	Substantially Equivalent	C.R. Bard, Inc.
K960074	CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR	Oct 16, 1996	Substantially Equivalent	Terumo Medical Corp.
K962667	CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR	Oct 07, 1996	Substantially Equivalent	Terumo Medical Corp.
K961000	CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR	Oct 02, 1996	Substantially Equivalent	Terumo Medical Corp.
K953835	LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR	Mar 15, 1996	Substantially Equivalent	Dideco S.R.L.
K951247	SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS	Nov 02, 1995	Substantially Equivalent	Baxter Healthcare Corp
K941473	MAXIMA PLUS HOLLOW FIBER OXYGENATOR	Jun 21, 1995	Substantially Equivalent	Medtronic Vascular
K941653	SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION	Aug 24, 1994	Substantially Equivalent	3M Health Care, Sarns
K941225	UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT	Aug 16, 1994	Substantially Equivalent	Baxter Healthcare Corp
K934292	WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR	Jul 26, 1994	Substantially Equivalent	Minntech Corp.
K931444	PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS	May 27, 1994	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K933586	MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE	Feb 07, 1994	Substantially Equivalent	Medtronic Vascular
K932252	AFFINITY HOLLOW FIBER OXYGENATOR	Nov 19, 1993	Substantially Equivalent	Avecor Cardiovascular, Inc.
K926467	COBE CMS-FS MEMBRANE OXYGENATOR	Nov 09, 1993	Substantially Equivalent	Cobe Cardiovascular, Inc.
K922799	CAPIOX SX HOLLOW FIBER OXYGENATOR	Sep 02, 1993	Substantially Equivalent	Terumo Medical Corp.
K926226	INTERSEPT FILTERED CARDIOTOMY RESERVOIR	Jun 22, 1993	Substantially Equivalent	Medtronic Vascular
K925076	SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.	Jun 07, 1993	Substantially Equivalent	3M Health Care, Sarns
K925075	SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR	Jun 07, 1993	Substantially Equivalent	3M Health Care, Sarns
K923272	COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR	May 11, 1993	Substantially Equivalent	Cobe Laboratories, Inc.
K925626	MAXIMA PLUS HOLLOW FIBER OXYGENATOR	Feb 05, 1993	Substantially Equivalent	Medtronic Vascular
K922933	SORIN MONOLYRH INTEGRATED MEMBRANE LUNG	Nov 30, 1992	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K920889	MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS	Sep 15, 1992	Substantially Equivalent	Medtronic Vascular
K912082	SAFE II	Dec 04, 1991	Substantially Equivalent	Polystan A/S
K912079	SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY	Oct 23, 1991	Substantially Equivalent	3M Health Care, Sarns
K912920	SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER	Sep 25, 1991	Substantially Equivalent	3M Health Care, Ltd.
K912655	MINIMAX OXYGENATION SYSTEM	Sep 13, 1991	Substantially Equivalent	Medtronic Vascular
K897068	MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR	Aug 28, 1991	Substantially Equivalent	Medtronic Vascular
K912078	SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION	Aug 20, 1991	Substantially Equivalent	3M Health Care, Sarns
K911227	NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS	May 29, 1991	Substantially Equivalent	3M Health Care, Sarns
K910107	DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD	Apr 10, 1991	Substantially Equivalent	Baxter Healthcare Corp
K903436	SARNS MEMBRANE OXGENATOR PART NUMBER 9443	Oct 19, 1990	Substantially Equivalent	3M Health Care, Sarns
K901253	(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000	Sep 05, 1990	Substantially Equivalent	Bio Medicus, Inc.
K901624	SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.	Jul 03, 1990	Substantially Equivalent	Shiley, Inc.
K901250	PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR	Jun 11, 1990	Substantially Equivalent	Shiley, Inc.
K901249	PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR	Jun 11, 1990	Substantially Equivalent	Shiley, Inc.
K896978	CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE	Feb 28, 1990	Substantially Equivalent	Medtronic Vascular
K894826	UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF	Feb 28, 1990	Substantially Equivalent	Bentley Laboratories, Inc.
K896671	SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461	Feb 14, 1990	Substantially Equivalent	3M Company
K892664	CARDIOPULMONARY SUPPORT (CPS) SYSTEM	Feb 13, 1990	Substantially Equivalent	Bard Cardiosurgery Div
K893704	SAFE-1	Dec 22, 1989	Substantially Equivalent	Polystan C/O Vitalcor, Inc.
K895632	SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380	Dec 12, 1989	Substantially Equivalent	3M Company
K893207	CLOSED CHEST SUPPORT CIRCUIT	Dec 12, 1989	Substantially Equivalent	Medtronic Blood Systems, Inc.
K895393	SARNS INGANT MEMBRANE OXYGENATOR	Dec 04, 1989	Substantially Equivalent	3M Company
K894970	WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR	Nov 01, 1989	Substantially Equivalent	Minntech Corp.
K892641	BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES	Nov 01, 1989	Substantially Equivalent	Bard Cardiosurgery Div
K894630	SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR	Oct 20, 1989	Substantially Equivalent	Shiley, Inc.
K894103	SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II	Sep 21, 1989	Substantially Equivalent	Scimed Life Systems, Inc.
K891687	EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE	May 31, 1989	Substantially Equivalent	Medtronic Blood Systems, Inc.
K891230	MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.	May 19, 1989	Substantially Equivalent	Medtronic Blood Systems, Inc.
K890808	SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV	May 01, 1989	Substantially Equivalent	3M Company
K882892	MEMBRANE OXYGENATOR	Sep 27, 1988	Substantially Equivalent	Baxter Bentley Laboratories, Inc.
K883054	SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II	Sep 26, 1988	Substantially Equivalent	Scimed Life Systems, Inc.
K883053	SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A	Sep 26, 1988	Substantially Equivalent	Scimed Life Systems, Inc.
K880021	COBE CML3	Apr 01, 1988	Substantially Equivalent	Cobe Laboratories, Inc.
K874841	INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER	Feb 02, 1988	Substantially Equivalent	Bentley Laboratories, Inc.
K873923	INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER	Nov 06, 1987	Substantially Equivalent	American Bentley
K872107	WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR	Aug 28, 1987	Substantially Equivalent	Minntech Corp.
K872133	OXYGENATOR MODEL NO. BENTLEY 5 PLUS	Aug 24, 1987	Substantially Equivalent	American Bentley
K864235	BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600	Jan 02, 1987	Substantially Equivalent	C.R. Bard, Inc.
K863476	SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO	Nov 25, 1986	Substantially Equivalent	Scimed Life Systems, Inc.
K863515	MODIFIED SARNS OXYGENATOR SYSTEM	Nov 18, 1986	Substantially Equivalent	3M Health Care, Sarns
K863249	OXYGENATOR MODEL NO. BENTLEY-10 PLUS	Oct 20, 1986	Substantially Equivalent	American Bentley
K861641	HEPARIN-COATED EXTRACORPOREAL CIRCUITS	Sep 29, 1986	Substantially Equivalent	American Bentley
K862918	SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM	Sep 23, 1986	Substantially Equivalent	Scimed Life Systems, Inc.
K860673	OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B	Jun 26, 1986	Substantially Equivalent	American Bentley
K861177	CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR	May 28, 1986	Substantially Equivalent	Terumo Medical Corp.
K860539	SARNS OXYGENATOR SYSTEM	Apr 29, 1986	Substantially Equivalent	3M Health Care, Sarns
K854045	MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED	Dec 16, 1985	Substantially Equivalent	American Bentley
K853251	J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO	Oct 16, 1985	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K853080	WILLIAM HARVEY HYBID OXYGENATOR H-1700	Oct 11, 1985	Substantially Equivalent	C.R. Bard, Inc.
K851035	AMERICAN BENTLEY OXYGENATOR MAX-2	May 16, 1985	Substantially Equivalent	American Bentley
K850630	BLOOD OXYGENATOR MODEL NO. MAX-5	Mar 27, 1985	Substantially Equivalent	American Bentley
K844901	AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH	Mar 07, 1985	Substantially Equivalent	American Bentley
K842908	VARIABLE PRIME COBE MEMBRANE LUNG	Feb 01, 1985	Substantially Equivalent	Cobe Laboratories, Inc.
K843956	SCIMED II MEMBRANE OXYGENATOR SYSTEM	Jan 08, 1985	Substantially Equivalent	Scimed Life Systems, Inc.
K843955	EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR	Nov 29, 1984	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K841476	TUBULAR HOLLOW FIBER MEMBRANE	Aug 03, 1984	Substantially Equivalent	American Bentley
K833078	HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000	Jan 27, 1984	Substantially Equivalent	Cordis Corp.
K833670	BOS-CM40,50 HOLDER & RESERVOIR BAG	Jan 03, 1984	Substantially Equivalent	American Bentley
K833518	BLOOD OXYGENATOR HEAT EXHANGER COATING	Dec 29, 1983	Substantially Equivalent	American Bentley
K833253	SHILEY M2000 MEMBRANE OXYGENATOR	Dec 01, 1983	Substantially Equivalent	Shiley, Inc.
K831894	BLOOD OXYGENATOR 5070	Oct 20, 1983	Substantially Equivalent	Shiley, Inc.
K831895	BLOOD OXYGENATOR 50 70/S	Oct 19, 1983	Substantially Equivalent	Shiley, Inc.
K831705	WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD	Jul 18, 1983	Substantially Equivalent	C.R. Bard, Inc.
K831122	WILLIAM HARVEY H-1700 ADULT BLOOD OXYG-	May 25, 1983	Substantially Equivalent	C.R. Bard, Inc.
K830639	HI FLEX D-700 MODULAR BUBBLE OXYGENA-	May 25, 1983	Substantially Equivalent	Electromedics, Inc.
K830327	DOSIMETRIC RELEASE OF RADIATION DEV	Mar 24, 1983	Substantially Equivalent	American Bentley
K823273	BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.	Jan 05, 1983	Substantially Equivalent	Bentley Laboratories, Inc.
K823456	OXYGENATORS #BOS-10, 105, 5S	Dec 30, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K823343	OXYGENATOR 10	Dec 15, 1982	Substantially Equivalent	Gambro, Inc.
K823125	CAPIOX II	Nov 24, 1982	Substantially Equivalent	Terumo Medical Corp.
K822803	BLOOD OXYGENATORS #BOS-105S BOS-5S W/	Nov 01, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K821477	WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD	Nov 01, 1982	Substantially Equivalent	C.R. Bard, Inc.
K821216	INTERPULSE MEMBRANE OXYGENATOR	Jun 02, 1982	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K813255	LPM/50 MEMBRANE OXYGENATOR	Jan 18, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K812660	TERUMO HOLLOW FIBER OXYGENATOR	Dec 14, 1981	Substantially Equivalent	Terumo Medical Corp.
K811004	MANIFOLD	May 08, 1981	Substantially Equivalent	American Pharmaseal Div. Ahsc
K810532	DISPOSABLE STOPCOCK	Apr 23, 1981	Substantially Equivalent	Texas Medical Products, Inc.
K810505	CARDIOPULMONARY BYPASS OXYGENATOR	Apr 23, 1981	Substantially Equivalent	Cobe Laboratories, Inc.
K810470	SHILEY S-100A (ADULT) BLOOD OXYGENATOR	Apr 17, 1981	Substantially Equivalent	Shiley, Inc.
K803003	INTERPULSE MEMBRANE OXYGENATION SYSTEM	Jan 22, 1981	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K802970	TERUMO HOLLOW FIBER OXYGENATOR	Jan 22, 1981	Substantially Equivalent	Terumo America, Inc.
K803231	THB 6000 HARDSHELL BUBBLE OXYGENATOR	Jan 16, 1981	Substantially Equivalent	Travenol Laboratories, S.A.
K802720	SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S	Dec 16, 1980	Substantially Equivalent	Bentley Laboratories, Inc.
K802719	SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S	Dec 16, 1980	Substantially Equivalent	Bentley Laboratories, Inc.
K802328	DISP. TOUGY-BORST TYPE ADAPTOR W/PORT	Oct 10, 1980	Substantially Equivalent	Stanco Medical, Inc.
K801240	BUILT-IN TEMPERATURE MONITORING	Jun 04, 1980	Substantially Equivalent	Bentley Laboratories, Inc.
K800555	PARTNER SEVEN DISP. BUBBLE OXYGENATOR	Apr 04, 1980	Substantially Equivalent	Cardiovascular Research, Inc.
K790406	DELTA D-750 THERMAFLOW	Nov 13, 1979	Substantially Equivalent	Delta Medical Industries
K792039	WILLIAM HARVEY H-1500 BLOOD OXYGENATOR	Oct 30, 1979	Substantially Equivalent	C.R. Bard, Inc.
K790356	OXYGENATOR, COBE CATALOG #42-220	Mar 09, 1979	Substantially Equivalent	Cobe Laboratories, Inc.
K781842	OXYGENATOR, BLOOD BOS-10	Nov 08, 1978	Substantially Equivalent	Bentley Laboratories, Inc.
K780078	OXYGENATOR, BUBBLE TYPE	Sep 14, 1978	Substantially Equivalent	Bentley Laboratories, Inc.
K781223	OXYGENATOR, BLOOD, INFANT/PEDIATRIC	Jul 27, 1978	Substantially Equivalent	Shiley, Inc.
K772284	BUBBLE-TYPE OXYGENATOR	Feb 02, 1978	Substantially Equivalent	Cobe Laboratories, Inc.
K772237	OXYGENATOR, BUBBLE	Dec 13, 1977	Substantially Equivalent	Shiley, Inc.
K760824	TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I	Nov 12, 1976	Substantially Equivalent	Travenol Laboratories, S.A.