510(k) K070159 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
PRELUDE SHEATH INTRODUCER
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Jun 21, 2007 |
| Received | Jan 17, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2024 | Merit Medical Systems, Inc. Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) Open, Classified |
DRE | None listed |
| May 10, 2023 | Merit Medical Systems, Inc. COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units Open, Classified |
DYB | None listed |
| Jun 22, 2015 | Merit Medical Systems, Inc. Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO
The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduct Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.