510(k) K254208 ยท QEZ Aspiration Thrombectomy Catheter
FLOWRUNNER Aspiration System
| Applicant | Expanse Medical, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Mar 20, 2026 |
| Received | Dec 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254208
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.