Catheter

Main information

  • Trade name:
  • Catheter introducing sheath
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Catheter introducing sheath
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217340
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217340

William A Cook Australia Pty Ltd - Catheter introducing sheath

ARTG entry for

Medical Device Included Class IIa

Sponsor

William A Cook Australia Pty Ltd

Postal Address

95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

15/11/2013

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

Cook Incorporated

750 Daniels Way

Bloomington, Indiana, 47404

United States Of America

Products

1. Catheter introducing sheath

Product Type

Medical device system

Effective date

15/11/2013

GMDN

10678 Catheter introducing sheath

Intended purpose

The Percutaneous Introducer Set is used for antegrade placement of a safety wire prior to endourological

procedures. The set consists of a wire guide, dilator, introducer, sheath.

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 02:35:59 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