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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Lumen Ecmo Cannula
510(k) Number K251831
Device Name Bio-Medicus Life Support Catheter and Introducer
Applicant
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact Elizabeth Rose
Correspondent
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Correspondent Contact Elizabeth Rose
Regulation Number870.4100
Classification Product Code
QHW  
Subsequent Product Code
DWF  
Date Received06/13/2025
Decision Date 01/15/2026
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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