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FDA 510(k)

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

K-Number: K251744 · 2026-01-16

ApplicantMedtronic
Decision Date2026-01-16
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2026-01-16 under approval number K251744. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter?

Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter is a medical device that received FDA 510(k) clearance on 2026-01-16. It is manufactured by Medtronic. The 510(k) number is K251744.

When was Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter approved by the FDA?

Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter received FDA 510(k) clearance on 2026-01-16, under approval number K251744.

What company makes Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter?

Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter is manufactured by Medtronic.

What is the FDA product code for Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter?

The FDA product code for Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter is DTM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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