# K062858: Modification to Glidesheath

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Oct 20, 2006 after 25 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: 2 generations back to K954234 (1995). 2 ancestors in all.
42 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033681: Glidesheath, Terumo Corp. (2003) Summary page 1.

## Most influential descendants
- K082644: Glidesheath (2008), 41 descendants of its own
- K102008: Glidesheath (2010), 17 descendants of its own
- K122980: Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ, Glidesheath Slender Model RM * RS6J10PQ (2012), 12 descendants of its own
- K142183: Glidesheath Slender (2014), 8 descendants of its own
- K111606: Pinnacle Precision Access System (2011), 7 descendants of its own

## Indications for use
The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

Source page: https://510kreport.com/device/K062858
Methodology: https://510kreport.com/methodology