LifeSPARC System
K-Number: K211830 · 2022-11-15
ApplicantCardiacassist, Inc.
Decision Date2022-11-15
Product CodeQNR
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
LifeSPARC System is a medical device manufactured by Cardiacassist, Inc.. It received FDA 510(k) clearance on 2022-11-15 under approval number K211830. The device is classified under product code QNR. 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 2022-11-15. It is manufactured by Cardiacassist, Inc.. The 510(k) number is K211830.
When was LifeSPARC System approved by the FDA?
LifeSPARC System received FDA 510(k) clearance on 2022-11-15, under approval number K211830.
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 QNR.
Other Devices by Cardiacassist, Inc.
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K230364VitalFlow ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
K234118CentriMag Acute Circulatory Support SystemABBOTT MEDICAL
K233736LifeSPARC SystemCardiacassist, 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.