510(k) K200083 ยท KRD Device, Vascular, For Promoting Embolization
EMBA Hourglass Peripheral Embolization Device (PED)
| Applicant | Embolic Acceleration, LLC, Miami FL, US |
| Decision | Substantially Equivalent, Feb 14, 2020 |
| Received | Jan 15, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200083
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.