510(k) K161064 ยท NRY Catheter, Thrombus Retriever
Penumbra System ACE 68 Reperfusion Catheter
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Jun 12, 2016 |
| Received | Apr 15, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161064
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.