510(k) K181051 ยท KRD Device, Vascular, For Promoting Embolization
IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
| Applicant | Shape Memory Medical, Santa Clara CA, US |
| Decision | Substantially Equivalent, Jun 22, 2018 |
| Received | Apr 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181051
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.