KFM · Class II · 21 CFR 870.4360

FDA Product Code KFM: Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

Leading manufacturers include Medtronic, Inc., Maquet Cardiopulmonary, AG and Qura S.R.L.

84
Total
84
Cleared
170d
Avg days
1977
Since
84 devices
49–72 of 84
Cleared Apr 09, 2002
CARDIOVENTION CORX SYSTEM, MODEL FG 0001
K012325
Cardiovention, Inc.
Cardiovascular · 260d
Cleared Apr 04, 2002
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998
Terumo Cardiovascular Systems Corp.
Cardiovascular · 7d
Cleared Feb 12, 2002
COBE REVOLUTION
K011835
Cobe Cardiovascular, Inc.
Cardiovascular · 245d
Cleared Nov 09, 2001
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM
K013393
A-Med Systems, Inc.
Cardiovascular · 25d
Cleared Aug 15, 2001
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209
Terumo Cardiovascular Systems Corp.
Cardiovascular · 30d
Cleared Nov 01, 2000
AB-180 XC SYSTEM, MODEL AB-180XC
K991783
Cardiacassist, Inc.
Cardiovascular · 526d
Cleared Aug 31, 2000
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
K991864
Jostra Medizintechnik AG
Cardiovascular · 457d
Cleared May 04, 2000
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
K992592
A-Med Systems, Inc.
Cardiovascular · 276d
Cleared Mar 24, 1999
IBC FLOPUMP, MODEL 6000
K983272
International Biophysics Corp.
Cardiovascular · 188d
Cleared Feb 25, 1998
BPX80 BIO-PUMP (BPX80)
K973011
Medtronic Bio-Medicus, Inc.
Cardiovascular · 196d
Cleared Feb 06, 1998
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)
K972740
Himex Production Corp.
Cardiovascular · 199d
Cleared Feb 25, 1997
CAPIOX SP PUMP HEAD
K962981
Terumo Medical Corp.
Cardiovascular · 208d
Cleared Apr 22, 1996
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
K952879
Baxter Healthcare Corp
Cardiovascular · 304d
Cleared Aug 15, 1995
CAPIOX SP PUMP HEAD
K943861
Terumo Corp.
Cardiovascular · 372d
Cleared Sep 28, 1994
LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
K933014
St. Jude Medical, Inc.
Cardiovascular · 464d
Cleared Sep 09, 1993
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
K915547
3M Health Care, Sarns
Cardiovascular · 638d
Cleared Jul 28, 1993
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
K915363
3M Health Care, Ltd.
Cardiovascular · 609d
Cleared May 21, 1992
LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP
K921550
St. Jude Medical, Inc.
Cardiovascular · 58d
Cleared Nov 07, 1991
DELPHIN II CENTRIFUGAL SYSTEM
K913176
3M Health Care, Sarns
Cardiovascular · 113d
Cleared Oct 28, 1991
SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
K912604
Aries Medical, Inc.
Cardiovascular · 150d
Cleared Dec 21, 1990
ARIES MELDICAL MODEL 2100HC HANK CRANK
K903925
Aries Medical, Inc.
Cardiovascular · 130d
Cleared Dec 17, 1990
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
K902404
3M Company
Cardiovascular · 201d
Cleared Jul 13, 1990
SARNS DELPHIN BASE ADAPTER WITH BATTERY
K902198
3M Company
Cardiovascular · 58d
Cleared Mar 28, 1990
SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY
K900601
3M Company
Cardiovascular · 48d