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 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
Cleared Sep 26, 1989
ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP
K894255
St. Jude Medical, Inc.
Cardiovascular · 98d
Cleared Jan 24, 1989
SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
K884659
3M Health Care, Sarns
Cardiovascular · 78d
Cleared Oct 13, 1988
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
K882758
3M Health Care, Sarns
Cardiovascular · 100d
Cleared Jan 15, 1986
ELECATH PULSATILE PERFUSION PUMP
K854975
Electro-Catheter Corp.
Cardiovascular · 34d
Cleared Aug 31, 1978
MODEL 1861 BLOOD PUMP
K780953
Medtronic Vascular
Cardiovascular · 83d