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510(k) K140999

TANDEMHEART VENO-VENOUS CANNULA by Cardiacassist, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2014
Date Received
April 18, 2014
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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  • 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)

Other clearances for product code DWF

  • K250937 — Venous Return Cannulae (March 11, 2026)
  • K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR18 (February 23, 2026)
  • 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)