Affinity Pixie? Arterial Filter with Balance? Biosurface; Affinity? Pediatric Arterial Blood Filter

About This 510(k) Submission

K251744 is an FDA 510(k) clearance for the Affinity Pixie? Arterial Filter with Balance? Biosurface; Affinity? Pediatric Arterial Blood Filter, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on January 16, 2026, 224 days after receiving the submission on June 6, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.