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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K203111
Device Name Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
Applicant
Medtronic
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact Kaitlin Cady
Correspondent
Medtronic
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact Kaitlin Cady
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received10/15/2020
Decision Date 09/16/2021
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
Recalls CDRH Recalls
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