K251744

Substantially Equivalent

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

Applicant: Medtronic
Product code: DTM
Advisory panel: Cardiovascular
Date received: 2025-06-06
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.