Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LifeSPARC System

K-Number: K232132 · 2023-08-03

ApplicantCardiacassist, Inc.
Decision Date2023-08-03
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LifeSPARC System is a medical device manufactured by Cardiacassist, Inc.. It received FDA 510(k) clearance on 2023-08-03 under approval number K232132. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeSPARC System?

LifeSPARC System is a medical device that received FDA 510(k) clearance on 2023-08-03. It is manufactured by Cardiacassist, Inc.. The 510(k) number is K232132.

When was LifeSPARC System approved by the FDA?

LifeSPARC System received FDA 510(k) clearance on 2023-08-03, under approval number K232132.

What company makes LifeSPARC System?

LifeSPARC System is manufactured by Cardiacassist, Inc..

What is the FDA product code for LifeSPARC System?

The FDA product code for LifeSPARC System is KFM.

Other Devices by Cardiacassist, Inc.

K162214Protek Solo 24 Fr Venous Cannula Set K160257PROTEK Duo 31 Fr. Veno-Venous Cannula Set K153295TandemLung Oxygenator K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set K181150ProtekDuo Mini Veno-Venous Cannula Set K183623LifeSPARC Pump, LifeSPARC Controller

View all 11 devices →

Related Devices (Code: KFM)

K170029FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation 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. K190650Revolution Centrifugal Blood PumpSorin Group Italia S.R.L. K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L K201068Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive SurfaceMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑