Gusta

Main information

  • Trade name:
  • Gusta NC PTCA Non-Compliant Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Gusta NC PTCA Non-Compliant Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216754
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216754

Demax Medical Pty Ltd - Gusta NC PTCA Non-Compliant Balloon Dilatation Catheter - Catheter,

angioplasty, balloon dilatation

ARTG entry for

Medical Device Included Class III

Sponsor

Demax Medical Pty Ltd

Postal Address

PO Box 391,BALGOWLAH, NSW, 2093

Australia

ARTG Start Date

31/10/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Beijing Demax Medical Technology Co Ltd

A13-7 Jingshengnansi Street Tongzhou District

Beijing, , 101102

China

Products

1. Gusta NC PTCA Non-Compliant Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation

Product Type

Single Device Product

Effective date

31/10/2013

GMDN

17184 Catheter, angioplasty, balloon dilatation

Functional description

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.

Intended purpose

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.

Variant information

Diameter (mm) 2.25mm-5.0mm

Length (mm) 8mm-20mm

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

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Public Summary

Page 1 of

Produced at 10.11.2017 at 04:22:16 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information