510(k) K093002 ยท KRD Device, Vascular, For Promoting Embolization
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Oct 28, 2009 |
| Received | Sep 28, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093002
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.