FDA.reportPublic FDA data

510(k) K232132

Device
LifeSPARC System
Applicant
Cardiacassist, Inc.
510(k) number
K232132
Product code
KFM
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-03
Date received
2023-07-18
Regulation
870.4360
Classification name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Arielle Drummond
Address
620 Alpha Dr. Pittsburgh PA US 15238 15238

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KFM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K200091Capiox iCP Centrifugal PumpTerumo Cardiovascular Systems Corporation2021-11-18
K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L2021-11-03
K193663FloPump 57mL Centrifugal PumpInternational Biophysics Corporation2021-03-10
K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L2020-09-02
K201068Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive SurfaceMedtronic, Inc.2020-05-21
K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L2020-04-13
K191077Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive MotorMedtronic, Inc.2019-08-27
K190650Revolution Centrifugal Blood PumpSorin Group Italia S.R.L.2019-08-07
K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.2019-07-09
K170029FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation2017-12-15
K132712AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTERMedtronic, Inc.2013-11-19