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
97–120 of 169
Cleared Oct 06, 1988
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
K882380
Scimed Life Systems, Inc.
Cardiovascular · 119d
Cleared Sep 28, 1988
SARNS INFANT VENOUS RESERVOIR MODEL #16387
K883345
3M Health Care, Sarns
Cardiovascular · 50d
Cleared Sep 16, 1988
SCIMED R30 SILICONE ASSIST RESERVOIR
K882720
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Nov 06, 1987
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
K873423
Johnson & Johnson Professionals, Inc.
Cardiovascular · 73d
Cleared Sep 30, 1987
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
K872719
Shiley, Inc.
Cardiovascular · 82d
Cleared Sep 23, 1987
SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET
K872720
Shiley, Inc.
Cardiovascular · 75d
Cleared Sep 23, 1987
EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR
K872721
Shiley, Inc.
Cardiovascular · 75d
Cleared Sep 23, 1987
EXPANDED USE FOR SHILEY 3L CARDF PLUS
K872722
Shiley, Inc.
Cardiovascular · 75d
Cleared Sep 14, 1987
WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR
K872378
C.R. Bard, Inc.
Cardiovascular · 87d
Cleared Jun 24, 1987
STAT-VAC CHEST DRAINAGE SYSTEM
K871775
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared May 06, 1987
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR
K870829
3M Health Care, Sarns
Cardiovascular · 64d
Cleared Feb 19, 1987
INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER
K864895
Johnson & Johnson Professionals, Inc.
Cardiovascular · 66d
Cleared Sep 29, 1986
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K862920
C.R. Bard, Inc.
Cardiovascular · 59d
Cleared Aug 19, 1986
MODIFIED CARDIOTOMY RESERVOIR 5M1470
K862357
3M Health Care, Sarns
Cardiovascular · 57d
Cleared Feb 10, 1986
SHILEY VENOUS RESERVOIR
K854841
Shiley, Inc.
Cardiovascular · 68d
Cleared Sep 25, 1985
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR
K852382
American Bentley
Cardiovascular · 112d
Cleared Jun 25, 1985
VENOUS RESERVOIR BAG BMR-1600
K851376
American Bentley
Cardiovascular · 78d
Cleared Jun 25, 1985
VENUOS RESERVOIR BAG BMR-1900
K851401
American Bentley
Cardiovascular · 77d
Cleared May 21, 1985
ACR 2500 CARDIOTOMY RESERVOIR FILTER
K842391
Electromedics, Inc.
Cardiovascular · 337d
Cleared Feb 14, 1985
CARDIOTOMY RESERVOIR BRS-XXX SERIES &
K843888
Gish Biomedical, Inc.
Cardiovascular · 135d
Cleared Jan 14, 1985
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
K843232
Shiley, Inc.
Cardiovascular · 150d
Cleared Jan 14, 1985
VENOUS RESERVOIR VRS-XXX SERIES
K844229
Gish Biomedical, Inc.
Cardiovascular · 74d
Cleared Jan 14, 1985
CARDIOTOMY RESERVOIR BCR-2000
K844366
American Bentley
Cardiovascular · 62d
Cleared Jan 14, 1985
CARDIOTOMY RESERVOIR W/FILTER BCR-2500
K844367
American Bentley
Cardiovascular · 62d