510(k) K142301 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
| Applicant | Cook Vascular, Inc., Vandergrift PA, US |
| Decision | Substantially Equivalent, Nov 12, 2014 |
| Received | Aug 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142301
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.