510(k) K142546 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Sep 25, 2014 |
| Received | Sep 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142546
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.