510(k) K043438 ยท DYB Introducer, Catheter
LARGE BORE SPLITTABLE INTRODUCER KIT
| Applicant | Thomas Medical Products, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Feb 15, 2005 |
| Received | Dec 14, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2026 | Merit Medical Systems, Inc. 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.