510(k) K183120 ยท KRD Device, Vascular, For Promoting Embolization
EmboCube Embolization Gelatin
| Applicant | Biosphere Medical, S.A., Roissy-En-France, FR |
| Decision | Substantially Equivalent, Aug 6, 2019 |
| Received | Nov 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183120
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.