510(k) K171820 ยท DYB Introducer, Catheter
Transjugular Liver Access Sets
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Mar 9, 2018 |
| Received | Jun 19, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171820
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2025 | Cook Incorporated Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers:
1) RTPS-100;
2) RTPS-100-10.0;
The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagno Open, Classified |
DYB | None listed |
| Dec 23, 2025 | Cook Incorporated Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100;
The Rsch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.