Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter— 510(k) K251744
Substantially EquivalentMedtronic
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. Device class: 2.
Clearance details
- Applicant
- Medtronic
- Product code
- Code DTM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4260
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mounds View, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.