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
121–144 of 169
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 Jan 14, 1977
CARDIOTOMY RESERVOIR
K770036
Shiley, Inc.
Cardiovascular · 4d
Cleared Nov 12, 1976
TMO OXYGENATOR RESERVOIR PUMP SET
K760823
Travenol Laboratories, S.A.
Cardiovascular · 30d