Product code KFM— Cardiovascular
CAPIOX SP PUMP HEAD
- Advisory panel
- Cardiovascular
- Total cleared
- 84
Adverse events under product code KFM
product code KFM- Death
- 109
- Injury
- 241
- Malfunction
- 1,779
- Total
- 2,129
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KFM
- K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
- K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
- K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
- K232132 — LifeSPARC System
- K220842 — Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
- K200091 — Capiox iCP Centrifugal Pump
- K201320 — Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
- K193663 — FloPump 57mL Centrifugal Pump
- K202169 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
- K201068 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
- K192850 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
- 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
- K190650 — Revolution Centrifugal Blood Pump
- K183623 — LifeSPARC Pump, LifeSPARC Controller
- K170029 — FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
- K132712 — AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
- K133265 — QUADROX-IR ADULT AND SMALL ADULT
- K112229 — SARN CENTRIFUGAL PUMP
- K110493 — TANDEMHEART PUMP
- K111972 — AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
- K111658 — AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
- K111657 — AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
- K111384 — LIFEBRIDGE
- K110845 — IMPELLA CONTROLLER WITH FLOW CONTROL
- K103357 — LIFEBRIDGE
- K093801 — IMPELLA CONTROLLER
- K100631 — AFFIITY CP CENTRIFUGAL BLOOD PUMP
- K090515 — ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
- K090051 — LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
- K083794 — MECC SET WITH BIOLINE COATING
- K083111 — IMPELLA 5.0 CATHETER FAMILY
- K082321 — TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
- K080470 — ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
- K073631 — ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
- K063723 — IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
- K080774 — CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
- K061072 — ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
- K051209 — LEVITRONIX CENTRIMAG BACK-UP CONSOLE
- K050890 — ECC.O SYSTEM
- K050109 — TRILLIUM BIOPUMP PLUS, MODEL BPX80T
- K033270 — NOVOSCI READY SYSTEM, MODEL RS-200
- K032040 — IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
- K031300 — IBC FLOPUMP WITH GBS COATING
- K030154 — IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
- K020271 — LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
- K030462 — COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
- K023132 — JOSTRA MECC SYSTEM
- K020529 — LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
- K012325 — CARDIOVENTION CORX SYSTEM, MODEL FG 0001
- K020998 — SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
- K011835 — COBE REVOLUTION
- K013393 — HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
- K012209 — CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
- K991783 — AB-180 XC SYSTEM, MODEL AB-180XC
- K991864 — ROTAFLOW CENTRIFUGAL PUMP SYSTEM
- K992592 — A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
- K983272 — IBC FLOPUMP, MODEL 6000
- K973011 — BPX80 BIO-PUMP (BPX80)
- K972740 — HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)
- K962981 — CAPIOX SP PUMP HEAD
- K952879 — SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
- K943861 — CAPIOX SP PUMP HEAD
- K933014 — LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
- K915547 — SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
- K915363 — SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
- K921550 — LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP
- K913176 — DELPHIN II CENTRIFUGAL SYSTEM
- K912604 — SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
- K903925 — ARIES MELDICAL MODEL 2100HC HANK CRANK
- K902404 — SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
- K902198 — SARNS DELPHIN BASE ADAPTER WITH BATTERY
- K900601 — SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY
- K894255 — ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP
- K884659 — SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
- K882129 — SYMBION CENTRIFUGAL BLOOD PUMP MODEL I
- K882758 — CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
- K854975 — ELECATH PULSATILE PERFUSION PUMP
- K852698 — BIO MEDICUS BIO PUMP MODEL BP-80
- K852807 — BIO MEDICUS BIO PUMP MODEL BP-50
- K851613 — CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER
- K851855 — BIO MEDICUS BIO PUMP MODEL BP-90
- K842007 — CENTRIMED SYSTEM 1
- K780953 — MODEL 1861 BLOOD PUMP
- K770937 — PUMP, BYPASS, PULSATILE, AVCO
Data sourced from openFDA. This site is unofficial and independent of the FDA.