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

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Bio-Excel Australia Pty Ltd

Klass:

Class III

Tillverkad av:

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

Terapiområde:

47732 - Angioplasty catheter, balloon dilatation, coronary, basic

Terapeutiska indikationer:

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).

Bemyndigande status:

A

Tillstånd datum:

2021-05-20