510(k) K141131 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
TIGHTRAIL MINI
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, May 23, 2014 |
| Received | May 1, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141131
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.