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

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

现在购买

下载 公众评估报告 (PAR)
19-07-2021

可用日期:

Bio-Excel Australia Pty Ltd

类:

Class III

厂商:

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

治疗领域:

47732 - Angioplasty catheter, balloon dilatation, coronary, basic

疗效迹象:

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).

授权状态:

A

授权日期:

2021-05-20

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