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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 K201057
Device Name Bio-Medicus Life Support Catheter and Introducer
Applicant
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Applicant Contact Juli Rubin
Correspondent
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Correspondent Contact Juli Rubin
Regulation Number870.4100
Classification Product Code
QHW  
Date Received04/21/2020
Decision Date 01/14/2022
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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