Device Dossier

Expressman Guiding Extension Catheter - Catheter, intravascular, guiding

Device Dossier for Expressman Guiding Extension Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor…

Intended purpose

Intended to be used in conjunction with guiding catheters to provide additional backup support to access discrete regions of the coronary vasculature, and to facilitate placement of devices.

Functional description

A single lumen rapid exchange catheter with a push rod section. The push rod is followed distally by a 35cm lumen section coated with hydrophilic coating. The shaft outer surface is hydrophilic coated. A marker band is located 2mm proximal to the distal tip to enable visibility by fluoroscopic methods. The device has two sets of positioning marks at 95cm (single mark) and 105cm (twin-mark) from the distal tip.

TGA Public Summary