510(k) K133631 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
LEXIPLIANT DILATOR SHEATH SET
| Applicant | Spectranetics Corporation, Colorado Springs CO, US |
| Decision | Substantially Equivalent, Mar 27, 2014 |
| Received | Nov 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133631
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.