DTN · Class II · 21 CFR 870.4400

FDA Product Code DTN: Reservoir, Blood, Cardiopulmonary Bypass

Leading manufacturers include Gish Biomedical, Inc., Shiley, Inc. and American Bentley.

169
Total
169
Cleared
109d
Avg days
1976
Since
169 devices
145–168 of 169
Cleared Apr 25, 1984
WILLIAM HARVEY H-4720 NON-FILTERED CAR
K841175
C.R. Bard, Inc.
Cardiovascular · 37d
Cleared Apr 17, 1984
WILLIAM HARVEY H-4700 FILTER/CARDIO
K841079
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Feb 04, 1984
CARDIOTOMY RESERVORS BCR-3000/3500-Q-120
K834373
American Bentley
Cardiovascular · 54d
Cleared Dec 29, 1983
USE OF TWEEN 80 AS A WETTING AGENT ON
K832802
American Bentley
Cardiovascular · 133d
Cleared Dec 27, 1983
CARDIOTOMY RESERVOIR-FILTER 050-108-050
K832671
Cobe Laboratories, Inc.
Cardiovascular · 140d
Cleared Dec 16, 1983
WILLIAM HARVEY H-71-5-F CARDIOTOMY
K833479
C.R. Bard, Inc.
Cardiovascular · 70d
Cleared Oct 31, 1983
VENOUS RESERVOIR
K832924
Shiley, Inc.
Cardiovascular · 63d
Cleared Aug 11, 1983
CARDIOPLEGIA RESERVOIR-#500926
K831966
American Bentley
Cardiovascular · 52d
Cleared Dec 30, 1982
VENOUS RESERVOIR BAG #BMR-1400
K823272
Bentley Laboratories, Inc.
Cardiovascular · 58d
Cleared Nov 24, 1982
EXV VENOUS RESERVOIR BAG & HOLDER
K823205
Extracorporeal Medical Specialities, Inc.
Cardiovascular · 28d
Cleared Jul 08, 1982
CARDIOTOMY RESERVOIRS
K820727
Erik Perfusion Services
Cardiovascular · 113d
Cleared Jun 17, 1982
WILLIAM HARVEY FLEX. VENOUS RESERVOIR
K821442
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared May 18, 1982
SC-2500F CARDIOTOMY RESERVIOR
K813268
Scimed Life Systems, Inc.
Cardiovascular · 179d
Cleared Oct 23, 1981
SUCKER CARDIOTOMY RETURN, C.P. BYPASS
K812455
Electromedics, Inc.
Cardiovascular · 56d
Cleared Jul 28, 1981
CORDIOTOMY RESERVOIR
K812008
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Jul 28, 1981
CARDIOTOMY RESERVOIR W/FILTER#BCR-3500
K812009
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Mar 05, 1981
CPS-1000
K802890
Gics Pharmaceuticals
Cardiovascular · 108d
Cleared Dec 22, 1980
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER
K803059
Extracorporeal Medical Specialities, Inc.
Cardiovascular · 19d
Cleared Sep 16, 1980
SHILEY UTILITY RESERVOIR
K802119
Shiley, Inc.
Cardiovascular · 12d
Cleared Apr 18, 1979
Q220F CARDITOMY RESERVOIR/MODIFIED
K790635
Bentley Laboratories, Inc.
Cardiovascular · 16d
Cleared Sep 27, 1978
DISPOSABLE CARDIOTOMY
K781577
C.R. Bard, Inc.
Cardiovascular · 12d
Cleared Apr 13, 1978
CARDIOTOMY RESERVOIR
K780517
Travenol Laboratories, S.A.
Cardiovascular · 13d
Cleared Apr 26, 1977
BLOOD RESERVOIR
K770546
Delta Medical Industries
Cardiovascular · 36d
Cleared Jan 14, 1977
CARDIOTOMY RESERVOIR
K770036
Shiley, Inc.
Cardiovascular · 4d