Hi-Torque

Main information

  • Trade name:
  • Hi-Torque JET Guide Wire - Catheter guide wire
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Hi-Torque JET Guide Wire - Catheter guide wire
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219368
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219368

Abbott Vascular Division of Abbott Australasia Pty Ltd - Hi-Torque JET Guide Wire - Catheter guide wire

ARTG entry for

Medical Device Included Class III

Sponsor

Abbott Vascular Division of Abbott Australasia Pty Ltd

Postal Address

Locked Bag 2005,North Ryde, NSW, 1670

Australia

ARTG Start Date

17/01/2014

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

Abbott Vascular

3200 Lakeside Drive

Santa Clara, CA, 95054

United States Of America

Products

1. Hi-Torque JET Guide Wire - Catheter guide wire

Product Type

Single Device Product

Effective date

17/01/2014

GMDN

35094 Catheter guide wire

Functional description

High-Torque Jet Guide wire with a diameter of 0.0145'' is provided in 190cm extendable, 250cm and

300cm exchange lengths. The distal core has a parabolic grind to reduce core diameter and stiffness for

flexibility and performance. The distal 28 cm portion of the wire is has a hydrophilic coating and

polyurethane coating loaded with tungsten to provide additional radiopacity. The proximal core is coated

with PTFE and a single coat of Microglide, and contains brachial and femoral markers.

Intended purpose

This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices

during percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with

compatible stent devices during therapeutic procedures.

The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel

structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish

the vasculature.

Variant information

Length (cm) 190 to 300

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

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 07:48:26 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