ClearanceBrief
Panels › Cardiovascular › Product code DTZ · Class 2

Oxygenator, Cardiopulmonary Bypass

Regulation 870.4350

5510(k)s in 12 months (255 all time)
0recalls in 12 months (107 all time)
98recalls that name a 510(k)
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Top companies in DTZ

Company510(k)sRecalls
Terumo Cardiovascular Systems Corp.1221
Maquet Medical Systems USA022
Sorin Group Italia S.R.L.220
Medtronic162
Cobe Cardiovascular, Inc.88
Medtronic Perfusion Systems114
American Bentley130
Maquet Cardiopulmonary, AG130
Dideco120
Medtronic Vascular120
Decided510(k)Device and applicantCode
Sep 29, 1986K861641HEPARIN-COATED EXTRACORPOREAL CIRCUITS
American Bentley
DTZ
Sep 23, 1986K862918SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
Scimed Life Systems, Inc.
DTZ
Jun 26, 1986K860673OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B
American Bentley
DTZ
May 28, 1986K861177CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR
Terumo Medical Corp.
DTZ
Apr 29, 1986K860539SARNS OXYGENATOR SYSTEM
3M Health Care, Sarns
DTZ
Dec 16, 1985K854045MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED
American Bentley
DTZ
Oct 16, 1985K853251J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO
Johnson & Johnson Professionals, Inc.
DTZ
Oct 11, 1985K853080WILLIAM HARVEY HYBID OXYGENATOR H-1700
C.R. Bard, Inc.
DTZ
May 16, 1985K851035AMERICAN BENTLEY OXYGENATOR MAX-2
American Bentley
DTZ
Mar 27, 1985K850630BLOOD OXYGENATOR MODEL NO. MAX-5
American Bentley
DTZ
Mar 7, 1985K844901AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH
American Bentley
DTZ
Feb 1, 1985K842908VARIABLE PRIME COBE MEMBRANE LUNG
Cobe Laboratories, Inc.
DTZ
Jan 8, 1985K843956SCIMED II MEMBRANE OXYGENATOR SYSTEM
Scimed Life Systems, Inc.
DTZ
Nov 29, 1984K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
Extracorporeal Medical Specialities, Inc.
DTZ
Aug 3, 1984K841476TUBULAR HOLLOW FIBER MEMBRANE
American Bentley
DTZ
Jan 27, 1984K833078HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000
Cordis Corp.
DTZ
Jan 3, 1984K833670BOS-CM40,50 HOLDER & RESERVOIR BAG
American Bentley
DTZ
Dec 29, 1983K833518BLOOD OXYGENATOR HEAT EXHANGER COATING
American Bentley
DTZ
Dec 1, 1983K833253SHILEY M2000 MEMBRANE OXYGENATOR
Shiley, Inc.
DTZ
Oct 20, 1983K831894BLOOD OXYGENATOR 5070
Shiley, Inc.
DTZ
Oct 19, 1983K831895BLOOD OXYGENATOR 50 70/S
Shiley, Inc.
DTZ
Jul 18, 1983K831705WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD
C.R. Bard, Inc.
DTZ
May 25, 1983K831122WILLIAM HARVEY H-1700 ADULT BLOOD OXYG-
C.R. Bard, Inc.
DTZ
May 25, 1983K830639HI FLEX D-700 MODULAR BUBBLE OXYGENA-
Electromedics, Inc.
DTZ
Mar 24, 1983K830327DOSIMETRIC RELEASE OF RADIATION DEV
American Bentley
DTZ
Jan 5, 1983K823273BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.
Bentley Laboratories, Inc.
DTZ
Dec 30, 1982K823456OXYGENATORS #BOS-10, 105, 5S
Bentley Laboratories, Inc.
DTZ
Dec 15, 1982K823343OXYGENATOR 10
Gambro, Inc.
DTZ
Nov 24, 1982K823125CAPIOX II
Terumo Medical Corp.
DTZ
Nov 1, 1982K822803BLOOD OXYGENATORS #BOS-105S BOS-5S W/
Bentley Laboratories, Inc.
DTZ
Nov 1, 1982K821477WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD
C.R. Bard, Inc.
DTZ
Jun 2, 1982K821216INTERPULSE MEMBRANE OXYGENATOR
Extracorporeal Medical Specialities, Inc.
DTZ
Jan 18, 1982K813255LPM/50 MEMBRANE OXYGENATOR
Travenol Laboratories, S.A.
DTZ
Dec 14, 1981K812660TERUMO HOLLOW FIBER OXYGENATOR
Terumo Medical Corp.
DTZ
May 8, 1981K811004MANIFOLD
American Pharmaseal Div. Ahsc
DTZ
Apr 23, 1981K810532DISPOSABLE STOPCOCK
Texas Medical Products, Inc.
DTZ
Apr 23, 1981K810505CARDIOPULMONARY BYPASS OXYGENATOR
Cobe Laboratories, Inc.
DTZ
Apr 17, 1981K810470SHILEY S-100A (ADULT) BLOOD OXYGENATOR
Shiley, Inc.
DTZ
Jan 22, 1981K803003INTERPULSE MEMBRANE OXYGENATION SYSTEM
Extracorporeal Medical Specialities, Inc.
DTZ
Jan 22, 1981K802970TERUMO HOLLOW FIBER OXYGENATOR
Terumo America, Inc.
DTZ
Jan 16, 1981K803231THB 6000 HARDSHELL BUBBLE OXYGENATOR
Travenol Laboratories, S.A.
DTZ
Dec 16, 1980K802720SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S
Bentley Laboratories, Inc.
DTZ
Dec 16, 1980K802719SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S
Bentley Laboratories, Inc.
DTZ
Oct 10, 1980K802328DISP. TOUGY-BORST TYPE ADAPTOR W/PORT
Stanco Medical, Inc.
DTZ
Jun 4, 1980K801240BUILT-IN TEMPERATURE MONITORING
Bentley Laboratories, Inc.
DTZ
Apr 4, 1980K800555PARTNER SEVEN DISP. BUBBLE OXYGENATOR
Cardiovascular Research, Inc.
DTZ
Nov 13, 1979K790406DELTA D-750 THERMAFLOW
Delta Medical Industries
DTZ
Oct 30, 1979K792039WILLIAM HARVEY H-1500 BLOOD OXYGENATOR
C.R. Bard, Inc.
DTZ
Mar 9, 1979K790356OXYGENATOR, COBE CATALOG #42-220
Cobe Laboratories, Inc.
DTZ
Nov 8, 1978K781842OXYGENATOR, BLOOD BOS-10
Bentley Laboratories, Inc.
DTZ

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