510(k) K162704 ยท HCG Device, Neurovascular Embolization
Axium Prime Detachable Coil System
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 3, 2017 |
| Received | Sep 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162704
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.