Class Class II

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

K251744 2026-01-16 Special
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Description

Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter by Medtronic, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251744
Clearance Date2026-01-16
Clearance TypeSpecial
Product CodeDTM
Regulation Number870.4260

Categories

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