# K193160: Glidesheath Slender Tibial Pedal Kit

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Coporation
- Decided: Dec 3, 2019 after 18 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: 7 generations back to K954234 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181237: Glidesheath Slender Tibial Pedal Kit, Terumo Medical Corporation (2018) Summary page 5.

## Indications for use
The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.

Source page: https://510kreport.com/device/K193160
Methodology: https://510kreport.com/methodology