# K962746: Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Oct 11, 1996 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
Longest line of descent: 1 generation back to K810675 (1981). 4 ancestors in all.
44 later devices descend from it; 3 cite it directly.
1 of 49 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945616: Cordis Avanti Catheter Sheath Introducer, Cordis Corp. (1995) Summary page 1.
- K932733: Cordis Catheter Sheath Introducer, Cordis Corp. (1993) Summary page 1.
- K911794: Cath Sheath Introducer Syst Plus W/Unistasis Valve, Cordis Corp. (1991) Summary page 1.
- K810675: Arrow Radial Artery Catheterization Set, Arrow Intl., Inc. (1981) 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 Avanti™ Trans-Radial Catheter Sheath Introducer kit is intended for use in (radial) arterial procedures requiring percutaneous introduction of catheters and other intravascular devices. As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simuitaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.

Source page: https://510kreport.com/device/K962746
Methodology: https://510kreport.com/methodology