510(k) K160219 ยท KRD Device, Vascular, For Promoting Embolization
Hilal Embolization MicroCoils
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Aug 3, 2016 |
| Received | Jan 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160219
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2022 | Cook Incorporated Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498) Open, Classified |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.