510(k) K223472 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Dec 15, 2022 |
| Received | Nov 17, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223472
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.