510(k) K233736

LifeSPARC System by Cardiacassist, Inc. — Product Code QNR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 19, 2024
Date Received: November 22, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Device Class: Class II
Regulation Number: 870.4100
Review Panel: CV
Submission Type

A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

Other clearances by Cardiacassist, Inc.

K232480 — ProtekDuo Veno-Venous Cannula Sets (October 6, 2023)
K232132 — LifeSPARC System (August 3, 2023)
K211830 — LifeSPARC System (November 15, 2022)
K202751 — TandemHeart Pump and Escort Controller (March 26, 2021)
K183623 — LifeSPARC Pump, LifeSPARC Controller (July 9, 2019)
K181150 — ProtekDuo Mini Veno-Venous Cannula Set (May 25, 2018)
K162181 — Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set (January 6, 2017)
K162214 — Protek Solo 24 Fr Venous Cannula Set (November 30, 2016)
K160257 — PROTEK Duo 31 Fr. Veno-Venous Cannula Set (March 4, 2016)
K153295 — TandemLung Oxygenator (February 26, 2016)

Other clearances for product code QNR

K250199 — VitalFlow Console (May 20, 2025)
K234118 — CentriMag Acute Circulatory Support System (January 26, 2024)
K223898 — VitalFlowTM Centrifugal Pump (August 25, 2023)
K230364 — VitalFlow Console (August 25, 2023)
K222038 — CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System (December 8, 2022)
K211830 — LifeSPARC System (November 15, 2022)
K202751 — TandemHeart Pump and Escort Controller (March 26, 2021)