510(k) K150360 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Mar 4, 2015 |
| Received | Feb 12, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150360
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.