510(k) K260635 ยท KRD Device, Vascular, For Promoting Embolization
HARBOR Occlusion Device
| Applicant | Nuvascular, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 12, 2026 |
| Received | Feb 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260635
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.