510(k) K250971 ยท KRD Device, Vascular, For Promoting Embolization
Embosphere Microspheres
| Applicant | Biosphere Medical, S.A., Roissy-En-France, FR |
| Decision | Substantially Equivalent, May 16, 2025 |
| Received | Mar 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250971
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.