510(k) K251744 · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter
| Applicant | Medtronic, Mounds View MN, US |
| Decision | Substantially Equivalent, Jan 16, 2026 |
| Received | Jun 6, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251744
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.