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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 K240534
Device Name Bio-Medicus Life Support Catheter and Introducer
Applicant
Medtronic Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Applicant Contact Anna Wetherille
Correspondent
Medtronic Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Correspondent Contact Kimberly Peterson
Regulation Number870.4100
Classification Product Code
QHW  
Subsequent Product Code
DWF  
Date Received02/26/2024
Decision Date 04/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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