510(k) K172117 ยท DYB Introducer, Catheter
Prelude Pursuit Splittable Sheath Introducer
| Applicant | Merit Medical Systems, Inc., Malvern PA, US |
| Decision | Unknown, Sep 11, 2017 |
| Received | Jul 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172117
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
Prelude Prestige (Introducer Catheter), REF:
PLP-2505/A
PLP-2514/A
PLP-2516/A
The in Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.