510(k) K061000 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
| Applicant | Cook Vascular, Inc., Vandergrift PA, US |
| Decision | Substantially Equivalent, May 10, 2006 |
| Received | Apr 11, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061000
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.