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510(k) K133236

TANDEMHEART FEMORAL VENOUS CANNULA SET by Cardiacassist, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2014
Date Received
October 21, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Cardiacassist, Inc.

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  • 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)

Other clearances for product code DWF

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  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
  • K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (June 27, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (May 31, 2024)