510(k) K250909 ยท DYB Introducer, Catheter
Prelude Wave Hydrophilic Sheath Introducer
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Apr 25, 2025 |
| Received | Mar 26, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250909
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.