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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 K253203
Device Name Retrograde Coronary Sinus Perfusion Cannulae
Applicant
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Applicant Contact Megan Smith
Correspondent
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Correspondent Contact Megan Smith
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/26/2025
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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