510(k) K173750 ยท DYB Introducer, Catheter
Prelude IDeal Hydrophilic Sheath Introducer
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Feb 15, 2018 |
| Received | Dec 8, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173750
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2025 | Merit Medical Systems, Inc. Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D Open, Classified |
DYB | None listed |
| Sep 12, 2019 | Merit Medical Systems, Inc. Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.