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510(k) K120543

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2012
Date Received
February 23, 2012
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

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  • 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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  • K253106 — AngioVac Cannula (October 24, 2025)
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