ClearanceBrief
Panels › Cardiovascular › Product code DTN · Class 2

Reservoir, Blood, Cardiopulmonary Bypass

Regulation 870.4400

1510(k)s in 12 months (169 all time)
0recalls in 12 months (47 all time)
46recalls that name a 510(k)
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Top companies in DTN

Company510(k)sRecalls
Datascope Corporation022
Gish Biomedical, Inc.160
Medtronic Perfusion Systems214
Shiley, Inc.140
American Bentley110
Circulatory Technology, Inc.47
Cobe Cardiovascular, Inc.92
C.R. Bard, Inc.100
Sorin Biomedical, Inc.80
Sorin Group Italia S.R.L.80
Decided510(k)Device and applicantCode
Jun 6, 1991K905818VACUUM-ASSISTED BLOOD COLLECTION SYSTEM
Jtl Medical Corp.
DTN
Dec 17, 1990K903632INTERSEPT 1375 VENOUS RESERVOIR
Medtronic Vascular
DTN
Dec 17, 1990K902631COBE ICU CONVERSION KIT
Cobe Laboratories, Inc.
DTN
Dec 6, 1990K904040SOFTSHELL VENOUS RESERVOIR
C.R. Bard, Inc.
DTN
Apr 20, 1990K894664CAPIOX HARDSHELL VENOUS RESERVOIR
Terumo Medical Corp.
DTN
Mar 6, 1990K895356UNIVOX-IC
Baxter Healthcare Corp
DTN
Feb 28, 1990K893711DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
Shiley, Inc.
DTN
Jan 31, 1990K896414VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
Baxter Healthcare Corp
DTN
Dec 22, 1989K893705SAFE-1 VENOUS RESERVOIR
Polystan C/O Vitalcor, Inc., DK
DTN
Nov 3, 1989K895076CMS VRB-1200
Cobe Laboratories, Inc.
DTN
Apr 3, 1989K890077TRAUMAFUSE RAPID INFUSION DEVICE
The Traumafuse Co.
DTN
Jan 30, 1989K884872DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
Shiley, Inc.
DTN
Dec 5, 1988K882414BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
Gish Biomedical, Inc.
DTN
Nov 4, 1988K883923CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
Gish Biomedical, Inc.
DTN
Oct 6, 1988K882380SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
Scimed Life Systems, Inc.
DTN
Sep 28, 1988K883345SARNS INFANT VENOUS RESERVOIR MODEL #16387
3M Health Care, Sarns
DTN
Sep 16, 1988K882720SCIMED R30 SILICONE ASSIST RESERVOIR
Scimed Life Systems, Inc.
DTN
Nov 6, 1987K873423MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
Johnson & Johnson Professionals, Inc.
DTN
Sep 30, 1987K872719EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
Shiley, Inc.
DTN
Sep 23, 1987K872722EXPANDED USE FOR SHILEY 3L CARDF PLUS
Shiley, Inc.
DTN
Sep 23, 1987K872721EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR
Shiley, Inc.
DTN
Sep 23, 1987K872720SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET
Shiley, Inc.
DTN
Sep 14, 1987K872378WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR
C.R. Bard, Inc.
DTN
Jun 24, 1987K871775STAT-VAC CHEST DRAINAGE SYSTEM
Gish Biomedical, Inc.
DTN
May 6, 1987K870829SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR
3M Health Care, Sarns
DTN
Feb 19, 1987K864895INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER
Johnson & Johnson Professionals, Inc.
DTN
Sep 29, 1986K862920BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
C.R. Bard, Inc.
DTN
Aug 19, 1986K862357MODIFIED CARDIOTOMY RESERVOIR 5M1470
3M Health Care, Sarns
DTN
Feb 10, 1986K854841SHILEY VENOUS RESERVOIR
Shiley, Inc.
DTN
Sep 25, 1985K852382CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR
American Bentley
DTN
Jun 25, 1985K851401VENUOS RESERVOIR BAG BMR-1900
American Bentley
DTN
Jun 25, 1985K851376VENOUS RESERVOIR BAG BMR-1600
American Bentley
DTN
May 21, 1985K842391ACR 2500 CARDIOTOMY RESERVOIR FILTER
Electromedics, Inc.
DTN
Feb 14, 1985K843888CARDIOTOMY RESERVOIR BRS-XXX SERIES &
Gish Biomedical, Inc.
DTN
Feb 14, 1985K843595CARDIOTOMY RESERVOIR W/FILTER
Omnis Surgical, Inc.
DTN
Jan 14, 1985K844367CARDIOTOMY RESERVOIR W/FILTER BCR-2500
American Bentley
DTN
Jan 14, 1985K844366CARDIOTOMY RESERVOIR BCR-2000
American Bentley
DTN
Jan 14, 1985K844229VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX
Gish Biomedical, Inc.
DTN
Jan 14, 1985K843232SHILEY HARDSHELL VENOUS RESERVOIR W/INT
Shiley, Inc.
DTN
Aug 27, 1984K842620CARDIOTOMY RESERVOIR W/FILTER BCR-3500
American Bentley
DTN
Aug 17, 1984K842337SHILEY VENOUS RESERVOIR
Shiley, Inc.
DTN
Aug 10, 1984K842711SHILEY CARDIOTOMY RESERVOIR W/FILTER
Shiley, Inc.
DTN
Aug 3, 1984K841938CARDIOPLEGIA RESERVOIR CAS-2000
American Bentley
DTN
May 23, 1984K841031OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT
American Bentley
DTN
Apr 25, 1984K841175WILLIAM HARVEY H-4720 NON-FILTERED CAR
C.R. Bard, Inc.
DTN
Apr 17, 1984K841079WILLIAM HARVEY H-4700 FILTER/CARDIO
C.R. Bard, Inc.
DTN
Feb 4, 1984K834373CARDIOTOMY RESERVORS BCR-3000/3500-Q-120
American Bentley
DTN
Dec 29, 1983K832802USE OF TWEEN 80 AS A WETTING AGENT ON
American Bentley
DTN
Dec 27, 1983K832671CARDIOTOMY RESERVOIR-FILTER 050-108-050
Cobe Laboratories, Inc.
DTN
Dec 16, 1983K833479WILLIAM HARVEY H-71-5-F CARDIOTOMY
C.R. Bard, Inc.
DTN

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