Device Dossier

Ikazuchi Zero PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Ikazuchi Zero PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter,…

Intended purpose

This product is intended to be used for dilating the stenosis lesion in the coronary artery when performing percutaneous transluminal coronary angioplasty (PTCA).

Functional description

Ikazuchi Zero is a rapid exchange percutaneous transluminal coronary angioplasty balloon dilatation catheter. The distal side of the catheter is equipped with a balloon inflatable to a specific diameter and length at recommended pressures. Radiopague marker(s) allows for confirmation of balloon's position in the patient vessel under high resolution fluoroscopy. The inner lumen is used to facilitate passage of a 0.014" guide wire while the other lumen is used for inflation/deflation of balloon.

TGA Public Summary