510(k) K253717 · SHJ Thrombectomy Whole Blood Return System
Helo Return
| Applicant | Endovascular Engineering, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Oct 11, 2026 |
| Received | Nov 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253717
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.