510(k) K242676 ยท POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
| Applicant | Phenox Limited, Galway, IE |
| Decision | Substantially Equivalent, Feb 28, 2025 |
| Received | Sep 6, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242676
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.