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510(k) K994171

MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE by Medtronic Cardiac Surgical Products — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2000
Date Received
December 10, 1999
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 Medtronic Cardiac Surgical Products

  • K022272 — MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) (January 8, 2003)
  • K013013 — MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. (December 4, 2001)
  • K012143 — 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 (October 24, 2001)
  • K010737 — SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,788 (April 4, 2001)
  • K000776 — MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP (February 7, 2001)
  • K000274 — EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE (February 10, 2000)

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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)