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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 K260195
Device Name Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
Applicant
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55122
Applicant Contact Nina Vollmer
Correspondent
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55122
Correspondent Contact Nina Vollmer
Regulation Number870.4210
Classification Product Code
DWF  
Date Received01/22/2026
Decision Date 04/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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