Device Dossier

Amplatz Ultra Stiff Wire Guide - Catheter guide wire

Device Dossier for Amplatz Ultra Stiff Wire Guide - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor William A…

Intended purpose

Intended to facilitate the placement of devices during diagnostic and interventional procedures.

Functional description

The wire guide is inserted into the body through the lumen of a percutaneous entry needle, guiding sheath, or other interventional device. After insertion, medical imaging is used to maneuver the wire guide to the desired location within the body. Catheters or other devices can then be inserted over the wire guide and directed to the intended location.

TGA Public Summary