510(k) K053197 ยท HCG Device, Neurovascular Embolization
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
| Applicant | Cordis Neurovascular, Inc., Miami Lake FL, US |
| Decision | Substantially Equivalent, Dec 15, 2005 |
| Received | Nov 16, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053197
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.