510(k) K212784 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
TightRail Guardian Motorized Dilator Sheath
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Aug 24, 2022 |
| Received | Sep 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212784
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.