510(k) K192083 ยท KRD Device, Vascular, For Promoting Embolization
Okami Medical LOBO Vascular Occlusion System
| Applicant | Okami Medical, Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Oct 30, 2019 |
| Received | Aug 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192083
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.