510(k) K181300 ยท KRD Device, Vascular, For Promoting Embolization
Embosphere Microspheres
| Applicant | Biosphere Medical, S.A., Roissy-En-France, FR |
| Decision | Substantially Equivalent, Jul 16, 2018 |
| Received | May 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Merit Medical Systems, Inc. Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF:
S420GH/EUA, S620GH/EUA;
Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB;
Embosphere 900-1200 micrometer 2 mL Open, Classified |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.