K251744

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

510(k) number: K251744
Device name: Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter
Applicant: Medtronic MN · US
Product code: DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Decision date: 2026-01-16
Date received: 2025-06-06
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Cardiovascular

Also available from FDA: K251744.pdf

Official FDA record: K251744

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.