# K181237: Glidesheath Slender Tibial Pedal Kit

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: Aug 3, 2018 after 85 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: 6 generations back to K954234 (1995). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 14 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
- K230704: RAIN Sheath™ Tibial Pedal Introducer (2023), 0 descendants of its own
- K193160: Glidesheath Slender Tibial Pedal Kit (2019), 0 descendants of its own

## 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/K181237
Methodology: https://510kreport.com/methodology