Device Dossier

Flexor Tuohy-Borst Side-Arm Introducer - Catheter introducer

Device Dossier for Flexor Tuohy-Borst Side-Arm Introducer - Catheter introducer (Catheter introducing sheath, Class III, sponsor William A Cook). ARTG…

Intended purpose

The intended purpose of these devices is to serve as a pathway for other devices to be inserted into the vascular system. The introducer is not intended to be placed in the coronary or neuro vasculature.

Functional description

The device is introduced into the vasculature percutaneously using the Seldinger technique. The hollow access sheath of the introducer creates a passage through which other vascular devices can be inserted.

TGA Public Summary