Home / 510(k) Clearances / K232480

510(k) K232480

ProtekDuo Veno-Venous Cannula Sets by Cardiacassist, Inc. — Product Code PZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2023
Date Received
August 16, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dual Lumen Ecmo Cannula
Device Class
Class II
Regulation Number
870.4100
Review Panel
CV
Submission Type

Long term support greater than 6 hours for acute respiratory 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)
  • 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 PZS

  • K203409 — MC3 Crescent Jugular Dual Lumen Catheter (May 3, 2021)
  • K180151 — MC3 Jugular Dual Lumen Catheter (July 16, 2018)
  • K171610 — MC3 QuickFlow Dual Lumen Catheter (November 16, 2017)