FDA Product Code
FDA Product Code KFM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4360
510(k) Clearances — 84 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | Spectrum Medical S.R.L. | 2025-08-04 | Traditional | PDF ↗ |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | Spectrum Medical S.R.L. | 2025-06-24 | Traditional | PDF ↗ |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | Qura S.R.L | 2023-10-26 | Special | PDF ↗ |
| K232132 | LifeSPARC System | Cardiacassist, Inc. | 2023-08-03 | Special | PDF ↗ |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | Qura S.R.L | 2023-05-19 | Traditional | PDF ↗ |
| K200091 | Capiox iCP Centrifugal Pump | Terumo Cardiovascular Systems Corporation | 2021-11-18 | Traditional | PDF ↗ |
| K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | Qura S.R.L | 2021-11-03 | Traditional | PDF ↗ |
| K193663 | FloPump 57mL Centrifugal Pump | International Biophysics Corporation | 2021-03-10 | Traditional | PDF ↗ |
| K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | Qura S.R.L | 2020-09-02 | Special | PDF ↗ |
| K201068 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface | Medtronic, Inc. | 2020-05-21 | Special | PDF ↗ |
| K192850 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | Qura S.R.L | 2020-04-13 | Traditional | PDF ↗ |
| K191077 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor | Medtronic, Inc. | 2019-08-27 | Traditional | PDF ↗ |
| K190650 | Revolution Centrifugal Blood Pump | Sorin Group Italia S.R.L. | 2019-08-07 | Traditional | PDF ↗ |
| K183623 | LifeSPARC Pump, LifeSPARC Controller | Cardiacassist, Inc. | 2019-07-09 | Traditional | PDF ↗ |
| K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile | International Biophysics Corporation | 2017-12-15 | Traditional | PDF ↗ |
| K132712 | AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER | Medtronic, Inc. | 2013-11-19 | Traditional | PDF ↗ |
| K133265 | QUADROX-IR ADULT AND SMALL ADULT | Maquet Cardiopulmonary, AG | 2013-11-12 | Special | PDF ↗ |
| K112229 | SARN CENTRIFUGAL PUMP | Terumo Cardiovascular Systems | 2011-12-09 | Traditional | PDF ↗ |
| K110493 | TANDEMHEART PUMP | Cardiacassist, Inc. | 2011-09-20 | Traditional | PDF ↗ |
| K111972 | AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF | Medtronic, Inc. | 2011-07-27 | Special | PDF ↗ |
| K111658 | AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE | Medtronic, Inc. | 2011-06-28 | Special | PDF ↗ |
| K111657 | AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2011-06-23 | Special | PDF ↗ |
| K111384 | LIFEBRIDGE | Lifebridge Medizintechnik AG | 2011-05-24 | Special | PDF ↗ |
| K110845 | IMPELLA CONTROLLER WITH FLOW CONTROL | Abiomed, Inc. | 2011-04-27 | Special | PDF ↗ |
| K103357 | LIFEBRIDGE | Lifebridge Medizintechnik AG | 2010-12-27 | Special | PDF ↗ |
| K093801 | IMPELLA CONTROLLER | Abiomed, Inc. | 2010-07-08 | Traditional | PDF ↗ |
| K100631 | AFFIITY CP CENTRIFUGAL BLOOD PUMP | Medtronic, Inc. | 2010-06-22 | Traditional | PDF ↗ |
| K090515 | ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) | Maquet Cardiopulmonary, AG | 2009-12-18 | Special | PDF ↗ |
| K090051 | LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 | Levitronix, LLC | 2009-10-08 | Traditional | PDF ↗ |
| K083794 | MECC SET WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2009-04-21 | Traditional | PDF ↗ |
| K083111 | IMPELLA 5.0 CATHETER FAMILY | Abiomed, Inc. | 2009-04-16 | Traditional | PDF ↗ |
| K082321 | TERUMO ROCSAFE HYBRID PERFUSION SYSTEM | Terumo Cardiovascular Systems Corp. | 2009-02-13 | Traditional | PDF ↗ |
| K080470 | ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 | Maquet Cardiopulmonary, AG | 2008-09-12 | Special | PDF ↗ |
| K073631 | ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100 | Orqis Medical Corporation | 2008-06-27 | Traditional | PDF ↗ |
| K063723 | IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM | Abiomed, Inc. | 2008-05-30 | Traditional | PDF ↗ |
| K080774 | CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) | Terumo Cardiovascular Systems Corp. | 2008-04-17 | Traditional | PDF ↗ |
| K061072 | ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 | Maquet Cardiopulmonary, AG | 2006-05-23 | Traditional | PDF ↗ |
| K051209 | LEVITRONIX CENTRIMAG BACK-UP CONSOLE | Levitronix, LLC | 2005-09-08 | Special | PDF ↗ |
| K050890 | ECC.O SYSTEM | Dideco S.R.L. | 2005-05-05 | Special | PDF ↗ |
| K050109 | TRILLIUM BIOPUMP PLUS, MODEL BPX80T | Medtronic Perfusion Systems | 2005-02-11 | Special | PDF ↗ |
| K033270 | NOVOSCI READY SYSTEM, MODEL RS-200 | Novosci Corp. | 2004-02-13 | Traditional | PDF ↗ |
| K032040 | IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR | Dideco S.P.A. | 2003-07-09 | Special | PDF ↗ |
| K031300 | IBC FLOPUMP WITH GBS COATING | Gish Biomedical, Inc. | 2003-05-14 | Traditional | PDF ↗ |
| K030154 | IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR | Dideco S.P.A. | 2003-03-31 | Abbreviated | PDF ↗ |
| K020271 | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 | Levitronix, LLC | 2003-03-25 | Abbreviated | PDF ↗ |
| K030462 | COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 | Cobe Cardiovascular, Inc. | 2003-03-06 | Special | PDF ↗ |
| K023132 | JOSTRA MECC SYSTEM | Jostra AG | 2002-12-17 | Traditional | PDF ↗ |
| K020529 | LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2 | A-Med Systems, Inc. | 2002-08-26 | Traditional | PDF ↗ |
| K012325 | CARDIOVENTION CORX SYSTEM, MODEL FG 0001 | Cardiovention, Inc. | 2002-04-09 | Traditional | PDF ↗ |
| K020998 | SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X | Terumo Cardiovascular Systems Corp. | 2002-04-04 | Special | PDF ↗ |
| K011835 | COBE REVOLUTION | Cobe Cardiovascular, Inc. | 2002-02-12 | Abbreviated | PDF ↗ |
| K013393 | HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H | A-Med Systems, Inc. | 2001-11-09 | Special | PDF ↗ |
| K012209 | CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X | Terumo Cardiovascular Systems Corp. | 2001-08-15 | Special | PDF ↗ |
| K991783 | AB-180 XC SYSTEM, MODEL AB-180XC | Cardiacassist, Inc. | 2000-11-01 | Traditional | PDF ↗ |
| K991864 | ROTAFLOW CENTRIFUGAL PUMP SYSTEM | Jostra Medizintechnik AG | 2000-08-31 | Traditional | PDF ↗ |
| K992592 | A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 | A-Med Systems, Inc. | 2000-05-04 | Traditional | PDF ↗ |
| K983272 | IBC FLOPUMP, MODEL 6000 | International Biophysics Corp. | 1999-03-24 | Traditional | PDF ↗ |
| K973011 | BPX80 BIO-PUMP (BPX80) | Medtronic Bio-Medicus, Inc. | 1998-02-25 | Traditional | PDF ↗ |
| K972740 | HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01) | Himex Production Corp. | 1998-02-06 | Traditional | PDF ↗ |
| K962981 | CAPIOX SP PUMP HEAD | Terumo Medical Corp. | 1997-02-25 | Traditional | PDF ↗ |
| K952879 | SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT | Baxter Healthcare Corp | 1996-04-22 | Traditional | PDF ↗ |
| K943861 | CAPIOX SP PUMP HEAD | Terumo Corp. | 1995-08-15 | Traditional | PDF ↗ |
| K933014 | LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI | St. Jude Medical, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K915547 | SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT | 3M Health Care, Sarns | 1993-09-09 | Traditional | PDF ↗ |
| K915363 | SARNS 7850 CENTRIFUGAL PUMP (MODIFIED) | 3M Health Care, Ltd. | 1993-07-28 | Traditional | PDF ↗ |
| K921550 | LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP | St. Jude Medical, Inc. | 1992-05-21 | Traditional | PDF ↗ |
| K913176 | DELPHIN II CENTRIFUGAL SYSTEM | 3M Health Care, Sarns | 1991-11-07 | Traditional | PDF ↗ |
| K912604 | SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF | Aries Medical, Inc. | 1991-10-28 | Traditional | PDF ↗ |
| K903925 | ARIES MELDICAL MODEL 2100HC HANK CRANK | Aries Medical, Inc. | 1990-12-21 | Traditional | PDF ↗ |
| K902404 | SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW | 3M Company | 1990-12-17 | Traditional | PDF ↗ |
| K902198 | SARNS DELPHIN BASE ADAPTER WITH BATTERY | 3M Company | 1990-07-13 | Traditional | PDF ↗ |
| K900601 | SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY | 3M Company | 1990-03-28 | Traditional | PDF ↗ |
| K894255 | ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP | St. Jude Medical, Inc. | 1989-09-26 | Traditional | PDF ↗ |
| K884659 | SARNS 9000 WITH CENTRIFUGAL PUMP OPTION | 3M Health Care, Sarns | 1989-01-24 | Traditional | PDF ↗ |
| K882129 | SYMBION CENTRIFUGAL BLOOD PUMP MODEL I | Symbion, Inc. | 1988-11-03 | Traditional | PDF ↗ |
| K882758 | CENTRIFUGAL PUMP SYSTEM LX/DX VERSION | 3M Health Care, Sarns | 1988-10-13 | Traditional | PDF ↗ |
| K854975 | ELECATH PULSATILE PERFUSION PUMP | Electro-Catheter Corp. | 1986-01-15 | Traditional | PDF ↗ |
| K852807 | BIO MEDICUS BIO PUMP MODEL BP-50 | Bio Medicus, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K852698 | BIO MEDICUS BIO PUMP MODEL BP-80 | Bio Medicus, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K851613 | CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER | Centrimed Corp. | 1985-06-19 | Traditional | PDF ↗ |
| K851855 | BIO MEDICUS BIO PUMP MODEL BP-90 | Bio Medicus, Inc. | 1985-06-19 | Traditional | PDF ↗ |
| K842007 | CENTRIMED SYSTEM 1 | Centrimed Corp. | 1984-08-03 | Traditional | PDF ↗ |
| K780953 | MODEL 1861 BLOOD PUMP | Medtronic Vascular | 1978-08-31 | Traditional | PDF ↗ |
| K770937 | PUMP, BYPASS, PULSATILE, AVCO | Avco Medical Products | 1977-11-17 | Traditional | PDF ↗ |
Product code KFM · Class II · Cardiovascular. Data: openFDA.