Summary for ARTG Entry:
Demax Medical Pty Ltd - Gusta NC PTCA Non-Compliant Balloon Dilatation Catheter - Catheter,
angioplasty, balloon dilatation
ARTG entry for
Medical Device Included Class III
Demax Medical Pty Ltd
PO Box 391,BALGOWLAH, NSW, 2093
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Beijing Demax Medical Technology Co Ltd
A13-7 Jingshengnansi Street Tongzhou District
Beijing, , 101102
1. Gusta NC PTCA Non-Compliant Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation
Single Device Product
17184 Catheter, angioplasty, balloon dilatation
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.
PTCA Non-Compliant Balloon Dilatation Catheter is intended for balloon dilatation of a hemo-dynamically
significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the
purpose of improving myocardial perfusion. The catheter may also be intended for the treatment of
post-deployment stent expansion.
Diameter (mm) 2.25mm-5.0mm
Length (mm) 8mm-20mm
No Specific Conditions included on Record
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