510(k) K173831 ยท DYB Introducer, Catheter
Glidesheath Slender
| Applicant | Terumo Medical Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, May 8, 2018 |
| Received | Dec 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173831
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2026 | Terumo Medical Corporation GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060.
The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery. Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.