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
25–48 of 84
Cleared Dec 27, 2010
LIFEBRIDGE
K103357
Lifebridge Medizintechnik AG
Cardiovascular · 41d
Cleared Jul 08, 2010
IMPELLA CONTROLLER
K093801
Abiomed, Inc.
Cardiovascular · 210d
Cleared Jun 22, 2010
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631
Medtronic, Inc.
Cardiovascular · 109d
Cleared Dec 18, 2009
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
K090515
Maquet Cardiopulmonary, AG
Cardiovascular · 295d
Cleared Apr 21, 2009
MECC SET WITH BIOLINE COATING
K083794
Maquet Cardiopulmonary, AG
Cardiovascular · 120d
Cleared Apr 16, 2009
IMPELLA 5.0 CATHETER FAMILY
K083111
Abiomed, Inc.
Cardiovascular · 177d
Cleared Feb 13, 2009
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321
Terumo Cardiovascular Systems Corp.
Cardiovascular · 184d
Cleared Sep 12, 2008
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
K080470
Maquet Cardiopulmonary, AG
Cardiovascular · 204d
Cleared May 30, 2008
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
K063723
Abiomed, Inc.
Cardiovascular · 532d
Cleared Apr 17, 2008
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
K080774
Terumo Cardiovascular Systems Corp.
Cardiovascular · 29d
Cleared May 23, 2006
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
K061072
Maquet Cardiopulmonary, AG
Cardiovascular · 36d
Cleared Sep 08, 2005
LEVITRONIX CENTRIMAG BACK-UP CONSOLE
K051209
Levitronix, LLC
Cardiovascular · 120d
Cleared May 05, 2005
ECC.O SYSTEM
K050890
Dideco S.R.L.
Cardiovascular · 27d
Cleared Feb 11, 2005
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
K050109
Medtronic Perfusion Systems
Cardiovascular · 24d
Cleared Jul 09, 2003
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
K032040
Dideco S.P.A.
Cardiovascular · 8d
Cleared May 14, 2003
IBC FLOPUMP WITH GBS COATING
K031300
Gish Biomedical, Inc.
Cardiovascular · 20d
Cleared Mar 31, 2003
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
K030154
Dideco S.P.A.
Cardiovascular · 74d
Cleared Mar 06, 2003
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462
Cobe Cardiovascular, Inc.
Cardiovascular · 22d
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 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