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 Oct 08, 2009
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
K090051
Levitronix, LLC
Cardiovascular · 274d
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 Jun 27, 2008
ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
K073631
Orqis Medical Corporation
Cardiovascular · 184d
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 Feb 13, 2004
NOVOSCI READY SYSTEM, MODEL RS-200
K033270
Novosci Corp.
Cardiovascular · 126d
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 25, 2003
LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
K020271
Levitronix, LLC
Cardiovascular · 421d
Cleared Mar 06, 2003
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462
Cobe Cardiovascular, Inc.
Cardiovascular · 22d
Cleared Dec 17, 2002
JOSTRA MECC SYSTEM
K023132
Jostra AG
Cardiovascular · 88d
Cleared Aug 26, 2002
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
K020529
A-Med Systems, Inc.
Cardiovascular · 188d