510(k) K193576 ยท POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | Dec 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193576
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.