Main information

  • Trade name:
  • Curved 16Fr. Introducer Set - Femoral - Fascial tissue dilator, single-use
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Curved 16Fr. Introducer Set - Femoral - Fascial tissue dilator, single-use
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218574
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


William A Cook Australia Pty Ltd - Curved 16Fr. Introducer Set - Femoral - Fascial tissue dilator, single-use

ARTG entry for

Medical Device Included Class III


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 III



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. Curved 16Fr. Introducer Set - Femoral - Fascial tissue dilator, single-use

Product Type

Single Device Product

Effective date



46448 Fascial tissue dilator, single-use

Functional description

The 16Fr Curved Femoral Sheath Set is designed to add directional control to the Femoral Helical Loop

Basket/Tip Deflecting Wire Guide combination or to the Needle's Eye Snare. The indwelling object is

prepared for removal by advancing the 16Fr Curved Sheath over the object until the object enters the 16Fr


Intended purpose

This device is for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads,

fragments of catheter tubing or wire guides and other foreign objects.

Variant information

Nil variant (as 1 device) Nil

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 10:01:52 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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