510(k) K143255 ยท DYB Introducer, Catheter
Prelude SNAP Splittable Sheath Introducer
| Applicant | Merit Medical Systems, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Apr 9, 2015 |
| Received | Nov 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143255
| 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 (Introducer Catheter kit), REF:
For the introduction of various types Open, Classified |
DYB | None listed |
| Jun 30, 2021 | Merit Medical Systems, Inc. Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads an Terminated |
DYB | None listed |
| Jun 30, 2021 | Merit Medical Systems, Inc. Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads Terminated |
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.