510(k) K260508 ยท KRD Device, Vascular, For Promoting Embolization
LOBO Vascular Occlusion System
| Applicant | Okami Medical, Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Apr 10, 2026 |
| Received | Feb 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260508
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.