510(k) K192068 ยท HCG Device, Neurovascular Embolization
i-ED COIL
| Applicant | Kaneka Pharma America, LLC, New York NY, US |
| Decision | Substantially Equivalent, Apr 25, 2020 |
| Received | Aug 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192068
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.