# K102008: Glidesheath

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jul 21, 2010 after 5 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: 4 generations back to K954234 (1995). 9 ancestors in all.
17 later devices descend from it; 3 cite it directly.
1 of 27 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 3.

## Most influential descendants
- K111606: Pinnacle Precision Access System (2011), 7 descendants of its own
- K140543: Preludeease Hydrophilic Sheath Introducer (2014), 6 descendants of its own
- K150257: PreludeEASE Hydrophilic Sheath Introducer (2015), 5 descendants of its own
- K173750: Prelude IDeal Hydrophilic Sheath Introducer (2018), 4 descendants of its own
- K123475: Shoocin Introducer Kit (2014), 3 descendants of its own

## Recalls of this device
- May 30, 2013 · Class II · Z-1612-2013: Medical devices were incorrectly labeled with extended expiration dates.

## Indications for use
The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery. The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.

Source page: https://510kreport.com/device/K102008
Methodology: https://510kreport.com/methodology