FDA 510(k)

Filtre artériel Affinity Pixie™ avec Surface Biosurface™; Filtre sanguin artériel pédiatrique Affinity®

Numéro K : K251744 · 2026-01-16

Date de décision2026-01-16

Code produitDTM

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Medtronic. The 510(k) number is K251744.

When did Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter receive FDA 510(k) clearance?

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

Who is the listed applicant for Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter?

The FDA 510(k) record lists Medtronic as the applicant. This does not by itself establish the device manufacturer.

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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Source officielle

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