510(k) K143218 ยท HCG Device, Neurovascular Embolization
Penumbra Smart Coil
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Mar 18, 2015 |
| Received | Nov 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143218
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.