510(k) K063785 ยท NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
SPIDERFX EMBOLIC PROTECTION DEVICE
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jan 19, 2007 |
| Received | Dec 21, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063785
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.