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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 K190557
Device Name Bio-Medicus Insertion Kit
Applicant
Medtronic, Inc.
8200 Coral Street NE
Mounds View,  MN  55112
Applicant Contact Huda Yusuf
Correspondent
Medtronic, Inc.
8200 Coral Street NE
Mounds View,  MN  55112
Correspondent Contact Huda Yusuf
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/05/2019
Decision Date 04/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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