510(k) K181021 ยท KRD Device, Vascular, For Promoting Embolization
EmboCube Embolization Gelatin
| Applicant | Biosphere Medical, S.A., Roissy-En-France, FR |
| Decision | Substantially Equivalent, Sep 27, 2018 |
| Received | Apr 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181021
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.