# K142183: Glidesheath Slender

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corporation
- Decided: Nov 21, 2014 after 105 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954234 (1995). 10 ancestors in all.
8 later devices descend from it; 5 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122980: Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ, Glidesheath Slender Model RM * RS6J10PQ, Terumo Medical Corporation (2012) Summary page 5.

## Most influential descendants
- K181237: Glidesheath Slender Tibial Pedal Kit (2018), 2 descendants of its own
- K173831: Glidesheath Slender (2018), 1 descendant of its own
- K230704: RAIN Sheath™ Tibial Pedal Introducer (2023), 0 descendants of its own
- K220604: EXTesia Introducer Sheath Set (2022), 0 descendants of its own
- K193160: Glidesheath Slender Tibial Pedal Kit (2019), 0 descendants of its own

## Recalls of this device
- Jun 7, 2017 · Class II · Z-0219-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0227-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0214-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0216-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0217-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0221-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0226-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0228-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0229-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0218-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0220-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0222-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0224-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0225-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0215-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0223-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).
- Jun 7, 2017 · Class II · Z-0230-2018: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).

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

Source page: https://510kreport.com/device/K142183
Methodology: https://510kreport.com/methodology