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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K251258
Device Name MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula
Applicant
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Applicant Contact Stephen Beier
Correspondent
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Correspondent Contact Stephen Beier
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/23/2025
Decision Date 06/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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