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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 K230640
Device Name Affinity Fusion™ Oxygenator System
Applicant
Medtronic Inc.
7611 Northland Drive
Minneapolis,  MN  55428
Applicant Contact Aj Thakkar
Correspondent
Medtronic Inc.
7611 Northland Drive
Minneapolis,  MN  55428
Correspondent Contact Aj Thakkar
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received03/08/2023
Decision Date 04/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
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