510(k) K140543 ยท DYB Introducer, Catheter
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Oct 16, 2014 |
| Received | Mar 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140543
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2017 | Merit Medical Systems, Inc. PreludeEASE Hydrophilic Sheath Introducer Dilator
The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.