# K152173: Glidesheath

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: Dec 1, 2015 after 119 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954234 (1995). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082644: Glidesheath, Terumo Medical Corp. (2008) Summary page 6.

## Most influential descendants
- K173287: Elite HV Radial (2017), 0 descendants of its own

## Indications for use
The Glidesheath™ is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

Source page: https://510kreport.com/device/K152173
Methodology: https://510kreport.com/methodology