510(k) K080967 ยท HCG Device, Neurovascular Embolization
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
| Applicant | Cordis Neurovascular, Inc., Miami Lakes FL, US |
| Decision | Substantially Equivalent, May 2, 2008 |
| Received | Apr 4, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080967
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.