Gusta NC PTCA Non-Compliant Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
10-11-2017
Send request.
Available from:
Demax Medical Australia Pty Ltd
Class:
Class III
Manufactured by:
Beijing Demax Medical Technology Co Ltd A13-7 Jingshengnansi Street Tongzhou District, Beijing, 101102 China
Therapeutic area:
47732 - Angioplasty catheter, balloon dilatation, coronary, basic
Therapeutic indications:
The PTCA Non-Compliant Balloon Dilatation Catheter is designed to allow rapid exchange of the catheter using a guidewire. The proximal shaft is a PTFE coated stainless steel tube to allow pushability, trackability and crossability to ensure optimal balloon placement and expansion. Balloon material allows high pressure dilatation. Two radiopaque markers located in balloon to enable fluoroscopy. The PTCA Balloon Dilatation Catheter is intended for dilatation of the stenotic portion (non-CTO) of coronary arteries for the purpose of improving myocardial perfusion.
Authorization status:
A
Authorization date:
2013-10-31
