510(k) K162389 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Medcomp Vessel Dilator
| Applicant | Medcomp ( Medical Components), Harleysville PA, US |
| Decision | Substantially Equivalent, Jun 1, 2017 |
| Received | Aug 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162389
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.