510(k) K954317 ยท DYB Introducer, Catheter
DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS
| Applicant | Daig Corp., Minnetonka MN, US |
| Decision | Substantially Equivalent, Nov 28, 1995 |
| Received | Sep 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954317
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2019 | Abbott Medical Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 Terminated |
DYB | None listed |
| Oct 22, 2014 | St Jude Medical St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO.
The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), She Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.