Main information

  • Trade name:
  • Nephrostomy Tampanade Ballon Catheter - Balloon, intrauterine
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Nephrostomy Tampanade Ballon Catheter - Balloon, intrauterine
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218598
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


William A Cook Australia Pty Ltd - Nephrostomy Tampanade Ballon Catheter - Balloon, intrauterine

ARTG entry for

Medical Device Included Class IIa


William A Cook Australia Pty Ltd

Postal Address

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


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Cook Incorporated

750 Daniels Way

Bloomington, Indiana, 47404

United States Of America


1. Nephrostomy Tampanade Ballon Catheter - Balloon, intrauterine

Product Type

Medical device system

Effective date



12155 Balloon, intrauterine

Intended purpose

The Nephrostomy Tamponade Balloon Catheter is used for nephrostomy drainage, ureteral drainage and

dynamic tamponade to prevent haemorrhage following nephrolithotomy and percutaneous stone removal

from tracts 18.0 French and larger. The set contains a stylet, balloon catheter, inflation check valve and

Y-connecting tube.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 09:56:43 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.

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