# K911794: Cath Sheath Introducer Syst Plus W/Unistasis Valve

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Jul 19, 1991 after 88 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
No predicates in its family tree.
45 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K962746: Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit (1996), 44 descendants of its own
- 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

Source page: https://510kreport.com/device/K911794
Methodology: https://510kreport.com/methodology