510(k) K254035 · QEZ Aspiration Thrombectomy Catheter
Mayumi Thrombectomy System
| Applicant | MicroVention, Inc., d/b/a Terumo Neuro, Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Sep 3, 2026 |
| Received | Dec 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254035
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.