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510(k) K202751

TandemHeart Pump and Escort Controller by Cardiacassist, Inc. — Product Code QNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2021
Date Received
September 21, 2020
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.

  • K233736 — LifeSPARC System (January 19, 2024)
  • K232480 — ProtekDuo Veno-Venous Cannula Sets (October 6, 2023)
  • K232132 — LifeSPARC System (August 3, 2023)
  • K211830 — LifeSPARC System (November 15, 2022)
  • 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)
  • K233736 — LifeSPARC System (January 19, 2024)
  • K230364 — VitalFlow™ Console (August 25, 2023)
  • K223898 — VitalFlowTM Centrifugal Pump (August 25, 2023)
  • K222038 — CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (December 8, 2022)
  • K211830 — LifeSPARC System (November 15, 2022)