510(k) K252956 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
Helo Thrombectomy System
| Applicant | Endovascular Engineering, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Dec 18, 2025 |
| Received | Sep 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252956
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.