510(k) K210638 ยท HCG Device, Neurovascular Embolization
i-ED COIL System
| Applicant | Kaneka Medical America, LLC, New York NY, US |
| Decision | Substantially Equivalent, Mar 26, 2021 |
| Received | Mar 3, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210638
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.