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 1984-08-03

TUBULAR HOLLOW FIBER MEMBRANE

Applicant American Bentley

K number K841476

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DTZ 1984-01-27

HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000

Applicant Cordis Corp.

K number K833078

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DTZ 1984-01-03

BOS-CM40,50 HOLDER & RESERVOIR BAG

Applicant American Bentley

K number K833670

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DTZ 1983-12-29

BLOOD OXYGENATOR HEAT EXHANGER COATING

Applicant American Bentley

K number K833518

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DTZ 1983-12-01

SHILEY M2000 MEMBRANE OXYGENATOR

Applicant Shiley, Inc.

K number K833253

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DTZ 1983-10-20

BLOOD OXYGENATOR 5070

Applicant Shiley, Inc.

K number K831894

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DTZ 1983-10-19

BLOOD OXYGENATOR 50 70/S

Applicant Shiley, Inc.

K number K831895

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DTZ 1983-07-18

WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD

Applicant C.R. Bard, Inc.

K number K831705

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DTZ 1983-05-25

WILLIAM HARVEY H-1700 ADULT BLOOD OXYG-

Applicant C.R. Bard, Inc.

K number K831122

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DTZ 1983-05-25

HI FLEX D-700 MODULAR BUBBLE OXYGENA-

Applicant Electromedics, Inc.

K number K830639

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DTZ 1983-03-24

DOSIMETRIC RELEASE OF RADIATION DEV

Applicant American Bentley

K number K830327

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DTZ 1983-01-05

BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.

Applicant Bentley Laboratories, Inc.

K number K823273

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DTZ 1982-12-30

OXYGENATORS #BOS-10, 105, 5S

Applicant Bentley Laboratories, Inc.

K number K823456

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DTZ 1982-12-15

OXYGENATOR 10

Applicant Gambro, Inc.

K number K823343

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DTZ 1982-11-24

CAPIOX II

Applicant Terumo Medical Corp.

K number K823125

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DTZ 1982-11-01

BLOOD OXYGENATORS #BOS-105S BOS-5S W/

Applicant Bentley Laboratories, Inc.

K number K822803

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DTZ 1982-11-01

WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD

Applicant C.R. Bard, Inc.

K number K821477

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DTZ 1982-06-02

INTERPULSE MEMBRANE OXYGENATOR

Applicant Extracorporeal Medical Specialities, Inc.

K number K821216

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DTZ 1982-01-18

LPM/50 MEMBRANE OXYGENATOR

Applicant Travenol Laboratories, S.A.

K number K813255

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DTZ 1981-12-14

TERUMO HOLLOW FIBER OXYGENATOR

Applicant Terumo Medical Corp.

K number K812660

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DTZ 1981-05-08

MANIFOLD

Applicant American Pharmaseal Div. Ahsc

K number K811004

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DTZ 1981-04-23

DISPOSABLE STOPCOCK

Applicant Texas Medical Products, Inc.

K number K810532

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DTZ 1981-04-23

CARDIOPULMONARY BYPASS OXYGENATOR

Applicant Cobe Laboratories, Inc.

K number K810505

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DTZ 1981-04-17

SHILEY S-100A (ADULT) BLOOD OXYGENATOR

Applicant Shiley, Inc.

K number K810470

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DTZ 1981-01-22

INTERPULSE MEMBRANE OXYGENATION SYSTEM

Applicant Extracorporeal Medical Specialities, Inc.

K number K803003

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DTZ 1981-01-22

TERUMO HOLLOW FIBER OXYGENATOR

Applicant Terumo America, Inc.

K number K802970

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DTZ 1981-01-16

THB 6000 HARDSHELL BUBBLE OXYGENATOR

Applicant Travenol Laboratories, S.A.

K number K803231

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DTZ 1980-12-16

SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S

Applicant Bentley Laboratories, Inc.

K number K802720

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DTZ 1980-12-16

SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S

Applicant Bentley Laboratories, Inc.

K number K802719

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DTZ 1980-10-10

DISP. TOUGY-BORST TYPE ADAPTOR W/PORT

Applicant Stanco Medical, Inc.

K number K802328

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DTZ 1980-06-04

BUILT-IN TEMPERATURE MONITORING

Applicant Bentley Laboratories, Inc.

K number K801240

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DTZ 1980-04-04

PARTNER SEVEN DISP. BUBBLE OXYGENATOR

Applicant Cardiovascular Research, Inc.

K number K800555

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DTZ 1979-11-13

DELTA D-750 THERMAFLOW

Applicant Delta Medical Industries

K number K790406

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DTZ 1979-10-30

WILLIAM HARVEY H-1500 BLOOD OXYGENATOR

Applicant C.R. Bard, Inc.

K number K792039

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DTZ 1979-03-09

OXYGENATOR, COBE CATALOG #42-220

Applicant Cobe Laboratories, Inc.

K number K790356

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DTZ 1978-11-08

OXYGENATOR, BLOOD BOS-10

Applicant Bentley Laboratories, Inc.

K number K781842

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DTZ 1978-09-14

OXYGENATOR, BUBBLE TYPE

Applicant Bentley Laboratories, Inc.

K number K780078

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DTZ 1978-07-27

OXYGENATOR, BLOOD, INFANT/PEDIATRIC

Applicant Shiley, Inc.

K number K781223

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DTZ 1978-02-02

BUBBLE-TYPE OXYGENATOR

Applicant Cobe Laboratories, Inc.

K number K772284

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DTZ 1977-12-13

OXYGENATOR, BUBBLE

Applicant Shiley, Inc.

K number K772237

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DTZ 1976-11-12

TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I

Applicant Travenol Laboratories, S.A.

K number K760824

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