DeviceClearance

Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter— 510(k) K251744

Substantially Equivalent

Medtronic

FDA 510(k) clearance K251744 for Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter, Substantially Equivalent on 2026-01-16. Applicant: Medtronic.

Clearance details

Applicant
Medtronic
Product code
Code DTM
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mounds View, MN, US
Download summary PDFView on FDA.gov ↗

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