510(k) K152381 ยท DYB Introducer, Catheter
Prelude SNAP Splittable Hydrophilic Sheath Introducer
| Applicant | Merit Medical Systems, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 30, 2015 |
| Received | Aug 24, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152381
| 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 SNAP-H (Introducer Catheter kit), REF:
PLSH-1006/A
PLSH-1007/A
PLSH-1008/A
PL Open, Classified |
DYB | None listed |
| Dec 14, 2017 | Merit Medical Systems, Inc. PreludeSNAP Splittable Hydrophilic and
non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.