510(k) K150931 ยท KRD Device, Vascular, For Promoting Embolization
MReye Embolization Coils
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Dec 18, 2015 |
| Received | Apr 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150931
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.