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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Bio-Excel Australia Pty Ltd

Class:

Class III

Manufactured by:

Kaneka Corporation 3-18 2-Chome Nakanoshima, Kita Ku, Osaka, 530-8288 Japan

Therapeutic area:

47732 - Angioplasty catheter, balloon dilatation, coronary, basic

Therapeutic indications:

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

Authorization status:

A

Authorization date:

2021-05-20