Oxygenator, Cardiopulmonary Bypass
FDA product code DTZ · 241 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.4350
- Review panel
- CV
- Implant
- No
- Life sustaining
- Yes
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-11-12 – 2026-09-14
DTZ
2001-09-27
DTZ
2000-10-13
SAFE MINI
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DTZ
2000-06-05
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
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DTZ
2000-04-25
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
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DTZ
2000-04-25
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
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DTZ
2000-02-25
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
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DTZ
2000-02-17
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR
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DTZ
1999-11-05
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
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DTZ
1999-10-07
COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
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DTZ
1999-09-20
HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010
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DTZ
1999-09-15
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)
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DTZ
1999-03-09
MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0
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DTZ
1998-06-01
COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
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DTZ
1998-02-18
AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
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DTZ
1998-01-27
COBE OXYGENATOR PRODUCTS
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DTZ
1997-12-08
COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
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DTZ
1997-10-08
LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
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DTZ
1997-09-29
COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS
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DTZ
1997-07-07
CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
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DTZ
1997-05-06
CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR
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DTZ
1997-03-06
BIOCOR 200 HIGH PERFORMANCEOXYGENATOR
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DTZ
1997-02-04
SAFE MICRO
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DTZ
1996-12-16
MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER
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DTZ
1996-12-05
GISH RELIANCE OXYGENATOR (MODEL HFO)
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DTZ
1996-10-30
BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
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DTZ
1996-10-16
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR
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DTZ
1996-10-07
CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR
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DTZ
1996-10-02
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR
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DTZ
1996-03-15
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
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DTZ
1995-11-02
SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
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DTZ
1995-06-21
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
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DTZ
1994-08-24
SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION
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DTZ
1994-08-16
UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT
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DTZ
1994-07-26
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
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DTZ
1994-05-27
PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS
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DTZ
1994-02-07
MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE
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DTZ
1993-11-19
AFFINITY HOLLOW FIBER OXYGENATOR
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DTZ
1993-11-09
COBE CMS-FS MEMBRANE OXYGENATOR
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DTZ
1993-09-02
CAPIOX SX HOLLOW FIBER OXYGENATOR
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DTZ
1993-06-22
INTERSEPT FILTERED CARDIOTOMY RESERVOIR
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DTZ
1993-06-07
SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.
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DTZ
1993-06-07
SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR
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DTZ
1993-05-11
COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR
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DTZ
1993-02-05
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
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DTZ
1992-11-30
SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
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DTZ
1992-09-15
MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS
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DTZ
1991-12-04
SAFE II
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DTZ
1991-10-23
SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY
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DTZ
1991-09-25
SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
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DTZ
1991-09-13
MINIMAX OXYGENATION SYSTEM
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DTZ
1991-08-28
MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR
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DTZ
1991-08-20
SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION
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DTZ
1991-05-29
NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS
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DTZ
1991-04-10
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
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DTZ
1990-10-19
SARNS MEMBRANE OXGENATOR PART NUMBER 9443
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DTZ
1990-09-05
(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000
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DTZ
1990-07-03
SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.
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DTZ
1990-06-11
PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR
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DTZ
1990-06-11
PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
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DTZ
1990-02-28
CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
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DTZ
1990-02-28
UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
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DTZ
1990-02-14
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461
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DTZ
1990-02-13
CARDIOPULMONARY SUPPORT (CPS) SYSTEM
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DTZ
1989-12-22
SAFE-1
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DTZ
1989-12-12
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
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DTZ
1989-12-12
CLOSED CHEST SUPPORT CIRCUIT
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DTZ
1989-12-04
SARNS INGANT MEMBRANE OXYGENATOR
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DTZ
1989-11-01
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
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DTZ
1989-11-01
BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES
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DTZ
1989-10-20
SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR
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DTZ
1989-09-21
SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II
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DTZ
1989-05-31
EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
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DTZ
1989-05-19
MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.
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DTZ
1989-05-01
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV
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DTZ
1988-09-27
MEMBRANE OXYGENATOR
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DTZ
1988-09-26
SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
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DTZ
1988-09-26
SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A
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DTZ
1988-04-01
COBE CML3
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DTZ
1988-02-02
INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
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DTZ
1987-11-06
INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
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DTZ
1987-08-28
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
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DTZ
1987-08-24
OXYGENATOR MODEL NO. BENTLEY 5 PLUS
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DTZ
1987-01-02
BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600
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DTZ
1986-11-25
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
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DTZ
1986-11-18
MODIFIED SARNS OXYGENATOR SYSTEM
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DTZ
1986-10-20
OXYGENATOR MODEL NO. BENTLEY-10 PLUS
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DTZ
1986-09-29
HEPARIN-COATED EXTRACORPOREAL CIRCUITS
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DTZ
1986-09-23
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
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DTZ
1986-06-26
OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B
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DTZ
1986-05-28
CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR
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DTZ
1986-04-29
SARNS OXYGENATOR SYSTEM
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DTZ
1985-12-16
MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED
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DTZ
1985-10-16
J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO
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DTZ
1985-10-11
WILLIAM HARVEY HYBID OXYGENATOR H-1700
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DTZ
1985-05-16
AMERICAN BENTLEY OXYGENATOR MAX-2
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DTZ
1985-03-27
BLOOD OXYGENATOR MODEL NO. MAX-5
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DTZ
1985-03-07
AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH
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DTZ
1985-02-01
VARIABLE PRIME COBE MEMBRANE LUNG
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DTZ
1985-01-08
SCIMED II MEMBRANE OXYGENATOR SYSTEM
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DTZ
1984-11-29
EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
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