510(k) K141148 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
| Applicant | Cook Vascular, Inc., Vandergrift PA, US |
| Decision | Substantially Equivalent, Jul 1, 2014 |
| Received | May 5, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141148
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.