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
73–96 of 169
Cleared Jul 01, 1993
EL2-SERIES BLOOD COLLECTION REERVOIR
K930154
Electromedics, Inc.
Cardiovascular · 169d
Cleared Jun 22, 1993
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K930299
C.R. Bard, Inc.
Cardiovascular · 152d
Cleared May 13, 1993
CARDIOTOMY RESERVOIR W/20 MICRON FILITER
K920178
Lifestream Int'L, Inc.
Cardiovascular · 485d
Cleared Apr 20, 1993
PLEUR-EVAC CARDIOTOMY RESERVOIR
K925046
Deknatel, Inc.
Cardiovascular · 196d
Cleared Feb 19, 1993
ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
K926250
Electromedics, Inc.
Cardiovascular · 67d
Cleared Dec 23, 1992
VENOUS RESERVOIR W/CARDIOTOMY FILTER
K915573
Baxter Healthcare Corp
Cardiovascular · 377d
Cleared Oct 19, 1992
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
K920774
Medtronic Vascular
Cardiovascular · 242d
Cleared Oct 01, 1992
NEW COBE CARDIOPLEGIA SYSTEM
K920312
Cobe Cardiovascular, Inc.
Cardiovascular · 252d
Cleared Sep 03, 1992
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
K915737
Electromedics, Inc.
Cardiovascular · 258d
Cleared Jan 17, 1992
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
K913956
Bentley Laboratories, Inc.
Cardiovascular · 134d
Cleared Nov 15, 1991
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
K913692
Bentley Laboratories, Inc.
Cardiovascular · 88d
Cleared Aug 12, 1991
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790
Medtronic Vascular
Cardiovascular · 112d
Cleared Aug 09, 1991
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K911876
Shiley, Inc.
Cardiovascular · 102d
Cleared Dec 17, 1990
COBE ICU CONVERSION KIT
K902631
Cobe Laboratories, Inc.
Cardiovascular · 186d
Cleared Dec 17, 1990
INTERSEPT 1375 VENOUS RESERVOIR
K903632
Medtronic Vascular
Cardiovascular · 129d
Cleared Dec 06, 1990
SOFTSHELL VENOUS RESERVOIR
K904040
C.R. Bard, Inc.
Cardiovascular · 93d
Cleared Apr 20, 1990
CAPIOX HARDSHELL VENOUS RESERVOIR
K894664
Terumo Medical Corp.
Cardiovascular · 270d
Cleared Mar 06, 1990
UNIVOX-IC
K895356
Baxter Healthcare Corp
Cardiovascular · 190d
Cleared Feb 28, 1990
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K893711
Shiley, Inc.
Cardiovascular · 286d
Cleared Jan 31, 1990
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
K896414
Baxter Healthcare Corp
Cardiovascular · 84d
Cleared Nov 03, 1989
CMS VRB-1200
K895076
Cobe Laboratories, Inc.
Cardiovascular · 81d
Cleared Jan 30, 1989
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K884872
Shiley, Inc.
Cardiovascular · 70d
Cleared Dec 05, 1988
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
K882414
Gish Biomedical, Inc.
Cardiovascular · 175d
Cleared Nov 04, 1988
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
K883923
Gish Biomedical, Inc.
Cardiovascular · 49d