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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K251744
Device Name Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter
Applicant
Medtronic
8200 Coral Sea St. NE
Mounds View,  MN  55112
Applicant Contact Makella Daley
Correspondent
Medtronic
8200 Coral Sea St. NE
Mounds View,  MN  55112
Correspondent Contact Makella Daley
Regulation Number870.4260
Classification Product Code
DTM  
Date Received06/06/2025
Decision Date 01/16/2026
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
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