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510(k) K033416

SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE by Medtronic Perfusion Systems — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2003
Date Received
October 27, 2003
Clearance Type
Special
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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  • K061254 — EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 (June 23, 2006)
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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)