510(k) K213385 ยท KRD Device, Vascular, For Promoting Embolization
GEM
| Applicant | Obsidio, Inc., Columbia SC, US |
| Decision | Substantially Equivalent, Jul 1, 2022 |
| Received | Oct 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2024 | Boston Scientific Corporation Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 Open, Classified |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.