510(k) K250079 ยท KRD Device, Vascular, For Promoting Embolization
Ruby XL System
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Mar 14, 2025 |
| Received | Jan 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250079
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.