510(k) K192480 ยท KRD Device, Vascular, For Promoting Embolization
Torpedo Gelatin Foam
| Applicant | Biosphere Medical, S.A., Roissy-En-France, FR |
| Decision | Substantially Equivalent, Nov 21, 2019 |
| Received | Sep 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192480
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.