510(k) K261310 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
FlexTract Deflectable-Rotational Dilator Sheath Set
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Jul 27, 2026 |
| Received | Apr 21, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261310
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.