510(k) K262864 ยท QEZ Aspiration Thrombectomy Catheter
FLOWRUNNER Aspiration System
| Applicant | Expanse Medical, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Oct 26, 2026 |
| Received | Aug 14, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262864
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.