510(k) K111010 ยท NTE Temporary Carotid Catheter For Embolic Capture
SPIDERFX EMBOLIC PROTECTION DEVICE
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 27, 2011 |
| Received | Apr 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111010
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.