Reservoir, Blood, Cardiopulmonary Bypass

FDA product code DTN · 164 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.4400
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-12 – 2025-12-22

DTN 1990-03-06

UNIVOX-IC

Applicant Baxter Healthcare Corp

K number K895356

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DTN 1990-02-28

DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR

Applicant Shiley, Inc.

K number K893711

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DTN 1990-01-31

VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN

Applicant Baxter Healthcare Corp

K number K896414

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DTN 1989-12-22

SAFE-1 VENOUS RESERVOIR

Applicant Polystan C/O Vitalcor, Inc.

K number K893705

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DTN 1989-11-03

CMS VRB-1200

Applicant Cobe Laboratories, Inc.

K number K895076

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DTN 1989-04-03

TRAUMAFUSE RAPID INFUSION DEVICE

Applicant The Traumafuse Co.

K number K890077

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DTN 1989-01-30

DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR

Applicant Shiley, Inc.

K number K884872

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DTN 1988-12-05

BLOOD RESERVOIR, CARDIOPULMONARY BYPASS

Applicant Gish Biomedical, Inc.

K number K882414

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DTN 1988-11-04

CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES

Applicant Gish Biomedical, Inc.

K number K883923

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DTN 1988-10-06

SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR

Applicant Scimed Life Systems, Inc.

K number K882380

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DTN 1988-09-28

SARNS INFANT VENOUS RESERVOIR MODEL #16387

Applicant 3M Health Care, Sarns

K number K883345

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DTN 1988-09-16

SCIMED R30 SILICONE ASSIST RESERVOIR

Applicant Scimed Life Systems, Inc.

K number K882720

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DTN 1987-11-06

MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER

Applicant Johnson & Johnson Professionals, Inc.

K number K873423

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DTN 1987-09-30

EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER

Applicant Shiley, Inc.

K number K872719

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DTN 1987-09-23

EXPANDED USE FOR SHILEY 3L CARDF PLUS

Applicant Shiley, Inc.

K number K872722

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DTN 1987-09-23

EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR

Applicant Shiley, Inc.

K number K872721

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DTN 1987-09-23

SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET

Applicant Shiley, Inc.

K number K872720

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DTN 1987-09-14

WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR

Applicant C.R. Bard, Inc.

K number K872378

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DTN 1987-06-24

STAT-VAC CHEST DRAINAGE SYSTEM

Applicant Gish Biomedical, Inc.

K number K871775

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DTN 1987-05-06

SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR

Applicant 3M Health Care, Sarns

K number K870829

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DTN 1987-02-19

INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER

Applicant Johnson & Johnson Professionals, Inc.

K number K864895

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DTN 1986-09-29

BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR

Applicant C.R. Bard, Inc.

K number K862920

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DTN 1986-08-19

MODIFIED CARDIOTOMY RESERVOIR 5M1470

Applicant 3M Health Care, Sarns

K number K862357

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DTN 1986-02-10

SHILEY VENOUS RESERVOIR

Applicant Shiley, Inc.

K number K854841

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DTN 1985-09-25

CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR

Applicant American Bentley

K number K852382

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DTN 1985-06-25

VENUOS RESERVOIR BAG BMR-1900

Applicant American Bentley

K number K851401

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DTN 1985-06-25

VENOUS RESERVOIR BAG BMR-1600

Applicant American Bentley

K number K851376

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DTN 1985-05-21

ACR 2500 CARDIOTOMY RESERVOIR FILTER

Applicant Electromedics, Inc.

K number K842391

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DTN 1985-02-14

CARDIOTOMY RESERVOIR BRS-XXX SERIES &

Applicant Gish Biomedical, Inc.

K number K843888

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DTN 1985-02-14

CARDIOTOMY RESERVOIR W/FILTER

Applicant Omnis Surgical, Inc.

K number K843595

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DTN 1985-01-14

CARDIOTOMY RESERVOIR W/FILTER BCR-2500

Applicant American Bentley

K number K844367

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DTN 1985-01-14

CARDIOTOMY RESERVOIR BCR-2000

Applicant American Bentley

K number K844366

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DTN 1985-01-14

VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX

Applicant Gish Biomedical, Inc.

K number K844229

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DTN 1985-01-14

SHILEY HARDSHELL VENOUS RESERVOIR W/INT

Applicant Shiley, Inc.

K number K843232

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DTN 1984-08-27

CARDIOTOMY RESERVOIR W/FILTER BCR-3500

Applicant American Bentley

K number K842620

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DTN 1984-08-17

SHILEY VENOUS RESERVOIR

Applicant Shiley, Inc.

K number K842337

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DTN 1984-08-10

SHILEY CARDIOTOMY RESERVOIR W/FILTER

Applicant Shiley, Inc.

K number K842711

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DTN 1984-08-03

CARDIOPLEGIA RESERVOIR CAS-2000

Applicant American Bentley

K number K841938

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DTN 1984-05-23

OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT

Applicant American Bentley

K number K841031

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DTN 1984-04-25

WILLIAM HARVEY H-4720 NON-FILTERED CAR

Applicant C.R. Bard, Inc.

K number K841175

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DTN 1984-04-17

WILLIAM HARVEY H-4700 FILTER/CARDIO

Applicant C.R. Bard, Inc.

K number K841079

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DTN 1984-02-04

CARDIOTOMY RESERVORS BCR-3000/3500-Q-120

Applicant American Bentley

K number K834373

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DTN 1983-12-29

USE OF TWEEN 80 AS A WETTING AGENT ON

Applicant American Bentley

K number K832802

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DTN 1983-12-27

CARDIOTOMY RESERVOIR-FILTER 050-108-050

Applicant Cobe Laboratories, Inc.

K number K832671

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DTN 1983-12-16

WILLIAM HARVEY H-71-5-F CARDIOTOMY

Applicant C.R. Bard, Inc.

K number K833479

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DTN 1983-10-31

VENOUS RESERVOIR

Applicant Shiley, Inc.

K number K832924

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DTN 1983-08-11

CARDIOPLEGIA RESERVOIR-#500926

Applicant American Bentley

K number K831966

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DTN 1982-12-30

VENOUS RESERVOIR BAG #BMR-1400

Applicant Bentley Laboratories, Inc.

K number K823272

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DTN 1982-11-24

EXV VENOUS RESERVOIR BAG & HOLDER

Applicant Extracorporeal Medical Specialities, Inc.

K number K823205

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DTN 1982-07-08

CARDIOTOMY RESERVOIRS

Applicant Erik Perfusion Services

K number K820727

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DTN 1982-06-17

WILLIAM HARVEY FLEX. VENOUS RESERVOIR

Applicant C.R. Bard, Inc.

K number K821442

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DTN 1982-05-18

SC-2500F CARDIOTOMY RESERVIOR

Applicant Scimed Life Systems, Inc.

K number K813268

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DTN 1981-10-23

SUCKER CARDIOTOMY RETURN, C.P. BYPASS

Applicant Electromedics, Inc.

K number K812455

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DTN 1981-07-28

CARDIOTOMY RESERVOIR W/FILTER#BCR-3500

Applicant Bentley Laboratories, Inc.

K number K812009

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DTN 1981-07-28

CORDIOTOMY RESERVOIR

Applicant Bentley Laboratories, Inc.

K number K812008

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DTN 1981-03-05

CPS-1000

Applicant Gics Pharmaceuticals

K number K802890

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DTN 1980-12-22

INTERSEPT* VENOUS RESERVOIR BAG & HOLDER

Applicant Extracorporeal Medical Specialities, Inc.

K number K803059

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DTN 1980-09-16

SHILEY UTILITY RESERVOIR

Applicant Shiley, Inc.

K number K802119

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DTN 1979-04-18

Q220F CARDITOMY RESERVOIR/MODIFIED

Applicant Bentley Laboratories, Inc.

K number K790635

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DTN 1978-09-27

DISPOSABLE CARDIOTOMY; H-700F, H-700

Applicant C.R. Bard, Inc.

K number K781577

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DTN 1978-04-13

CARDIOTOMY RESERVOIR

Applicant Travenol Laboratories, S.A.

K number K780517

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DTN 1977-04-26

BLOOD RESERVOIR

Applicant Delta Medical Industries

K number K770546

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DTN 1977-01-14

CARDIOTOMY RESERVOIR

Applicant Shiley, Inc.

K number K770036

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DTN 1976-11-12

TMO OXYGENATOR RESERVOIR PUMP SET

Applicant Travenol Laboratories, S.A.

K number K760823

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