510(k) K190175 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
S-MAK XL
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Apr 10, 2019 |
| Received | Feb 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190175
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.