510(k) K261800 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
Helo Max Thrombectomy System (HEL2090)
| Applicant | Endovascular Engineering, Menlo Park CA, US |
| Decision | Substantially Equivalent, Sep 3, 2026 |
| Received | Jun 1, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261800
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.