510(k) K231539 ยท POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
pRESET LITE Thrombectomy Device
| Applicant | Phenox Limited, Galway, IE |
| Decision | Substantially Equivalent, Oct 21, 2023 |
| Received | May 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231539
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.