Device Dossier

Amplatzer™ Guidewire - Cardiac/peripheral vascular guidewire, single-use

Device Dossier for Amplatzer™ Guidewire - Cardiac/peripheral vascular guidewire, single-use (Cardiac/peripheral vascular guidewire, single-use, Class…

Intended purpose

The Amplatzer™ Guidewire is intended to facilitate the introduction and exchange of a delivery system or catheter within the vasculature and chambers of the heart. It is indicated for percutaneous transcatheter procedures in patients with heart defects.

Functional description

The guidewire is advanced under fluoroscopic guidance to the desired anatomical location in the vasculature and chambers of the heart. The tip of the guidewire can be straightened with the J-Tip straightener to facilitate insertion of the guidewire into the vasculature. A compatible delivery system or catheter is advanced over the guidewire prior to the removal of the guidewire.

TGA Public Summary