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 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 Jun 06, 1991
VACUUM-ASSISTED BLOOD COLLECTION SYSTEM
K905818
Jtl Medical Corp.
Cardiovascular · 157d
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 Dec 22, 1989
SAFE-1 VENOUS RESERVOIR
K893705
Polystan C/O Vitalcor, Inc.
Cardiovascular · 218d
Cleared Nov 03, 1989
CMS VRB-1200
K895076
Cobe Laboratories, Inc.
Cardiovascular · 81d
Cleared Apr 03, 1989
TRAUMAFUSE RAPID INFUSION DEVICE
K890077
The Traumafuse Co.
Cardiovascular · 84d
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
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