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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2022-11-15 under 510(k) 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. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K211830.

When did LifeSPARC System receive FDA 510(k) clearance?

LifeSPARC System received FDA 510(k) clearance on 2022-11-15, under 510(k) number K211830.

Who is the listed applicant for LifeSPARC System?

The FDA 510(k) record lists Cardiacassist, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LifeSPARC System?

The FDA product code for LifeSPARC System is QNR.

Other records listing Cardiacassist, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233736LifeSPARC SystemK232480ProtekDuo Veno-Venous Cannula SetsK232132LifeSPARC SystemK202751TandemHeart Pump and Escort ControllerK183623LifeSPARC Pump, LifeSPARC ControllerK181150ProtekDuo Mini Veno-Venous Cannula Set

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Related Devices (Code: QNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250199VitalFlow ConsoleMedtronic, Inc.K234118CentriMag™ Acute Circulatory Support SystemABBOTT MEDICALK233736LifeSPARC SystemCardiacassist, Inc.K230364VitalFlow™ ConsoleMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)K223898VitalFlowTM Centrifugal PumpMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)K222038CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support SystemAbbott (Formerly Thoratec Corporation)

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.

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