510(k) K251744

Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter by Medtronic — Product Code DTM

K251744 is an FDA 510(k) premarket notification submitted by Medtronic for the device "Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter". The FDA issued a decision of Substantially Equivalent on January 16, 2026. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Medtronic has at least 10 other 510(k) clearances on record.