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
73–84 of 84
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 Nov 03, 1988
SYMBION CENTRIFUGAL BLOOD PUMP MODEL I
K882129
Symbion, Inc.
Cardiovascular · 167d
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 Sep 30, 1985
BIO MEDICUS BIO PUMP MODEL BP-80
K852698
Bio Medicus, Inc.
Cardiovascular · 96d
Cleared Sep 30, 1985
BIO MEDICUS BIO PUMP MODEL BP-50
K852807
Bio Medicus, Inc.
Cardiovascular · 90d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER
K851613
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
BIO MEDICUS BIO PUMP MODEL BP-90
K851855
Bio Medicus, Inc.
Cardiovascular · 54d
Cleared Aug 03, 1984
CENTRIMED SYSTEM 1
K842007
Centrimed Corp.
Cardiovascular · 78d
Cleared Aug 31, 1978
MODEL 1861 BLOOD PUMP
K780953
Medtronic Vascular
Cardiovascular · 83d
Cleared Nov 17, 1977
PUMP, BYPASS, PULSATILE, AVCO
K770937
Avco Medical Products
Cardiovascular · 178d