Visions

Main information

  • Trade name:
  • Visions PV .035 - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Visions PV .035 - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219543
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219543

Life Healthcare Pty Ltd- Visions PV .035 - Transducer assembly, ultrasound, diagnostic, intracorporeal,

intravascular, single-use

ARTG entry for

Medical Device Included Class III

Sponsor

Life Healthcare Pty Ltd

Postal Address

PO Box 646,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

24/01/2014

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

Volcano Corporation

2870 Kilgore Road

Rancho Cordova, California, 95670

United States Of America

Products

1. Visions PV .035 - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use

Product Type

Single Device Product

Effective date

24/01/2014

GMDN

44141 Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use

Functional description

An over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The

transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue

and detects the subsequent echoes. The information from the echoes is used to generate real-time images

of the peripheral vessels. The catheter is introduced percutaneously or via surgical cutdown into the

vascular system, and is designed to track over 0.89-0.97mm guide wires.

Intended purpose

Intended for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by

providing a cross-sectional image of such vessels. It is designed for use as an adjunct to conventional

angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional

measurements from the image.

Variant information

Nil variant (as 1 device) Not applicable.

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 07:13:26 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

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