510(k) K140047 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
LEXICONTURE MECHANICAL DILATOR SHEATH SET
| Applicant | Spectranetics Corp., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Apr 9, 2014 |
| Received | Jan 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140047
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.