510(k) K162539 ยท POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Solitaire 2 Revascularization Device
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 10, 2016 |
| Received | Sep 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162539
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.