ClearanceBrief
Panels › Cardiovascular › Product code KFM · Class 2

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Regulation 870.4360

0510(k)s in 12 months (84 all time)
0recalls in 12 months (40 all time)
39recalls that name a 510(k)
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Top companies in KFM

Company510(k)sRecalls
Terumo Cardiovascular Systems613
Cardiac Assist, Inc09
Medtronic, Inc.70
Qura S.R.L51
Abiomed, Inc.41
Levitronix, LLC32
Maquet Cardiopulmonary, AG50
3M Health Care, Sarns40
Cardiacassist, Inc.40
Maquet Cardiovascular Us Sales, Llc04
Decided510(k)Device and applicantCode
Feb 12, 2002K011835COBE REVOLUTION
Cobe Cardiovascular, Inc.
KFM
Nov 9, 2001K013393HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
A-Med Systems, Inc.
KFM
Aug 15, 2001K012209CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
Terumo Cardiovascular Systems Corp.
KFM
Nov 1, 2000K991783AB-180 XC SYSTEM, MODEL AB-180XC
Cardiacassist, Inc.
KFM
Aug 31, 2000K991864ROTAFLOW CENTRIFUGAL PUMP SYSTEM
Jostra Medizintechnik AG
KFM
May 4, 2000K992592A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
A-Med Systems, Inc.
KFM
Mar 24, 1999K983272IBC FLOPUMP, MODEL 6000
International Biophysics Corp.
KFM
Feb 25, 1998K973011BPX80 BIO-PUMP (BPX80)
Medtronic Bio-Medicus, Inc.
KFM
Feb 6, 1998K972740HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)
Himex Production Corp.
KFM
Feb 25, 1997K962981CAPIOX SP PUMP HEAD
Terumo Medical Corp.
KFM
Apr 22, 1996K952879SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
Baxter Healthcare Corp
KFM
Aug 15, 1995K943861CAPIOX SP PUMP HEAD
Terumo Corp.
KFM
Sep 28, 1994K933014LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
St. Jude Medical, Inc.
KFM
Sep 9, 1993K915547SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
3M Health Care, Sarns
KFM
Jul 28, 1993K915363SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
3M Health Care, Ltd.
KFM
May 21, 1992K921550LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP
St. Jude Medical, Inc.
KFM
Nov 7, 1991K913176DELPHIN II CENTRIFUGAL SYSTEM
3M Health Care, Sarns
KFM
Oct 28, 1991K912604SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
Aries Medical, Inc.
KFM
Dec 21, 1990K903925ARIES MELDICAL MODEL 2100HC HANK CRANK
Aries Medical, Inc.
KFM
Dec 17, 1990K902404SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
3M Company
KFM
Jul 13, 1990K902198SARNS DELPHIN BASE ADAPTER WITH BATTERY
3M Company
KFM
Mar 28, 1990K900601SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY
3M Company
KFM
Sep 26, 1989K894255ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP
St. Jude Medical, Inc.
KFM
Jan 24, 1989K884659SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
3M Health Care, Sarns
KFM
Nov 3, 1988K882129SYMBION CENTRIFUGAL BLOOD PUMP MODEL I
Symbion, Inc.
KFM
Oct 13, 1988K882758CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
3M Health Care, Sarns
KFM
Jan 15, 1986K854975ELECATH PULSATILE PERFUSION PUMP
Electro-Catheter Corp.
KFM
Sep 30, 1985K852807BIO MEDICUS BIO PUMP MODEL BP-50
Bio Medicus, Inc.
KFM
Sep 30, 1985K852698BIO MEDICUS BIO PUMP MODEL BP-80
Bio Medicus, Inc.
KFM
Jun 19, 1985K851855BIO MEDICUS BIO PUMP MODEL BP-90
Bio Medicus, Inc.
KFM
Jun 19, 1985K851613CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER
Centrimed Corp.
KFM
Aug 3, 1984K842007CENTRIMED SYSTEM 1
Centrimed Corp.
KFM
Aug 31, 1978K780953MODEL 1861 BLOOD PUMP
Medtronic Vascular
KFM
Nov 17, 1977K770937PUMP, BYPASS, PULSATILE, AVCO
Avco Medical Products
KFM

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