Catheter

Main information

  • Trade name:
  • Catheter, gastrointestinal balloon
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Catheter, gastrointestinal balloon
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216598
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216598

Fujifilm Australia Pty Ltd - Catheter, gastrointestinal balloon

ARTG entry for

Medical Device Included Class IIa

Sponsor

Fujifilm Australia Pty Ltd

Postal Address

PO Box 57,BROOKVALE, NSW, 2100

Australia

ARTG Start Date

25/10/2013

Product category

Medical Device Class IIa

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

Fujifilm Corporation

26-30 Nishiazabu 2 Chome

MINATO KU TOKYO, , 106 8620

Japan

Products

1. Catheter, gastrointestinal balloon

Product Type

Single Device Product

Effective date

25/10/2013

GMDN

45712 Catheter, gastrointestinal balloon

Intended purpose

This product is a balloon for containing the ultrasonic transmitting medium to be used in combination with

an ultrasonic endoscope in a medical facility under the supervision of a physician. This product is not

intended to be used for children or infants.

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 04:46:48 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

13-7-2018

Turnpike LP Catheter (2018-06-28)

Turnpike LP Catheter (2018-06-28)

Health Canada

22-6-2018

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

FDA - U.S. Food and Drug Administration

22-6-2018

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients  https://go.usa.gov/xUqu9  #medicaldevice

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://go.usa.gov/xUqu9  #medicaldevice

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://go.usa.gov/xUqu9  #medicaldevice

FDA - U.S. Food and Drug Administration