510(k) K111987 ยท NTE Temporary Carotid Catheter For Embolic Capture
FIBERNET EMBOLIC PROTECTION DEVICE
| Applicant | Lumen Biomedical, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Aug 17, 2011 |
| Received | Jul 13, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111987
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.