Home / 510(k) Clearances / K183623

510(k) K183623

LifeSPARC Pump, LifeSPARC Controller by Cardiacassist, Inc. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2019
Date Received
December 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

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)
  • K202751 — TandemHeart Pump and Escort Controller (March 26, 2021)
  • 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 KFM

  • K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-N (August 4, 2025)
  • K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-N (June 24, 2025)
  • K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT) (October 26, 2023)
  • K232132 — LifeSPARC System (August 3, 2023)
  • K220842 — Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum P (May 19, 2023)
  • K200091 — Capiox iCP Centrifugal Pump (November 18, 2021)
  • K201320 — Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (November 3, 2021)
  • K193663 — FloPump 57mL Centrifugal Pump (March 10, 2021)
  • K202169 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood (September 2, 2020)
  • K201068 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Bala (May 21, 2020)