Curved

Main information

  • Trade name:
  • Curved Inner Femoral Sheath - Fascial tissue dilator, single-use
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Curved Inner Femoral Sheath - Fascial tissue dilator, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218575
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218575

William A Cook Australia Pty Ltd - Curved Inner Femoral Sheath - Fascial tissue dilator, single-use

ARTG entry for

Medical Device Included Class III

Sponsor

William A Cook Australia Pty Ltd

Postal Address

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

Australia

ARTG Start Date

16/12/2013

Product category

Medical Device Class III

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. Curved Inner Femoral Sheath - Fascial tissue dilator, single-use

Product Type

Single Device Product

Effective date

16/12/2013

GMDN

46448 Fascial tissue dilator, single-use

Functional description

The Curved Femoral Introducer Sheath is a long, flexible 12Fr cannula that has a curved tip to aid in the

guidance and placement of snaring instruments. It is designed to add directional control to the Helical

Loop Basket/Tip Deflecting Wire Guide combination or to the Needle's Eye Snare. It is also useful when

the intra-atrial position of the pacemaker is difficult to access with the Straight Inner Femoral Sheath.

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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 10:01:36 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