Catheter

Main information

  • Trade name:
  • Catheter, cholangiography
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Catheter, cholangiography
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217493
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217493

Device Technologies Australia Pty Ltd - Catheter, cholangiography

ARTG entry for

Medical Device Included Class Is

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

19/11/2013

Product category

Medical Device Class Is

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

medwork GmbH

Medworkring 1

Hochstadt, , 91315

Germany

Products

1. Catheter, cholangiography

Product Type

Single Device Product

Effective date

19/11/2013

GMDN

16429 Catheter, cholangiography

Intended purpose

ERCP-catheters are intended to probe the duodenal papilla and to inject the common bile and pancreatic

ducts with contrast medium during cholangiography.

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 02:10:23 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