510(k) K161333 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
TightRail Sub-C Rotating Dilator Sheath
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Jul 8, 2016 |
| Received | May 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161333
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.