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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 K241352
Device Name Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
Applicant
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Applicant Contact Kaitlin Cady
Correspondent
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Correspondent Contact Kaitlin Cady
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received05/13/2024
Decision Date 06/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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