510(k) K053195 ยท NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
SPIDERX EMBOLIC PROTECTION DEVICE
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jun 23, 2006 |
| Received | Nov 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053195
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.