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 Mar 10, 1997
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
K964973
Gish Biomedical, Inc.
Cardiovascular · 88d
Cleared Nov 01, 1996
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836
Medtronic Vascular
Cardiovascular · 172d
Cleared Mar 07, 1996
BIOCOR 200 HARDSHELL VENOUS RESERVIOR
K953821
Minntech Corp.
Cardiovascular · 205d
Cleared Jan 11, 1996
SOFT VENOUS RESERVOIR
K955046
Gish Biomedical, Inc.
Cardiovascular · 69d
Cleared May 19, 1995
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
K945065
Sorin Biomedical, Inc.
Cardiovascular · 217d
Cleared May 10, 1995
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
K941215
Sorin Biomedical, Inc.
Cardiovascular · 426d
Cleared Jun 20, 1994
AFFINITY CVR
K936003
Avecor Cardiovascular, Inc.
Cardiovascular · 186d
Cleared May 10, 1994
AFFINITY VENOUS RESERVIOR BAG
K935717
Avecor Cardiovascular, Inc.
Cardiovascular · 161d
Cleared Apr 15, 1994
SORIN BLOOD CARDIOPLEGIA SYSTEM
K934763
Sorin Biomedical, Inc.
Cardiovascular · 192d
Cleared Apr 15, 1994
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
K934847
Sorin Biomedical, Inc.
Cardiovascular · 189d
Cleared Mar 23, 1994
SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS
K936183
Sorin Biomedical, Inc.
Cardiovascular · 86d
Cleared Mar 01, 1994
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
K933713
Baxter Healthcare Corp
Cardiovascular · 214d
Cleared Feb 14, 1994
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
K936286
Gish Biomedical, Inc.
Cardiovascular · 76d
Cleared Nov 02, 1993
SORIN MONOLYTH VENOUS RESERVOIR
K933481
Sorin Biomedical, Inc.
Cardiovascular · 125d
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 21, 1992
BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV
K913915
Bard Cardiosurgery Div
Cardiovascular · 140d