# K173831: Glidesheath Slender

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: May 8, 2018 after 141 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954234 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142183: Glidesheath Slender, Terumo Medical Corporation (2014) Summary page 5.

## Most influential descendants
- K220604: EXTesia Introducer Sheath Set (2022), 0 descendants of its own

## Recalls of this device
- Jun 15, 2026 · Class II · Z-2930-2026: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

## Indications for use
The Glidesheath Slender is indicated to facilitate placing a catheter through the skin into the radial artery.

Source page: https://510kreport.com/device/K173831
Methodology: https://510kreport.com/methodology