Device Dossier

RAIDEN 3 PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for RAIDEN 3 PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

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

Raiden 3 is a rapid exchange percutaneous transluminal coronary angioplasty balloon dilatation catheter. The distal side of the catheter is equipped with a balloon inflation to a specific diameter and length at recommended pressures. Radiopaque marker (s) allows for confirmation of balloon's position in patient vessel under high resolution fluoroscopy. The inner lumen of the catheter is used to facilitate passage of 0.014" guide-wire and the other lumen for inflation/deflation of the balloon.

TGA Public Summary