Bard

Main information

  • Trade name:
  • Bard Snare Retrieval Kit - Vena cava filter extraction/repositioning kit
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bard Snare Retrieval Kit - Vena cava filter extraction/repositioning kit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217878
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217878

Bard Australia Pty Ltd - Bard Snare Retrieval Kit - Vena cava filter extraction/repositioning kit

ARTG entry for

Medical Device Included Class III

Sponsor

Bard Australia Pty Ltd

Postal Address

PO Box 613,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

29/11/2013

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

Heraeus Medical Components LLC

2605 Fernbrook Lane North Suite J

Plymouth, MN, 55447

United States Of America

Products

1. Bard Snare Retrieval Kit - Vena cava filter extraction/repositioning kit

Product Type

Single Device Product

Effective date

29/11/2013

GMDN

45162 Vena cava filter extraction/repositioning kit

Functional description

The Bard Snare Retrieval Kit includes a single loop snare and two catheters for use with either a dual or

single sheath retrieval technique. The retrieval kit consists of a nitinol 6 Fr ID snare with a 20mm diameter

radiopaque loop, 9 Fr ID retrieval sheath, and 11 Fr ID access sheath. The snare catheter, retrieval

sheath, & access sheath have radiopaque marker bands at the distal ends for enhanced fluoroscopic

visualization.

Intended purpose

The Bard® Snare Retrieval Kit is intended for use to percutaneously remove all Bard® optional vena cava

filters with a retrieval hook.

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 12:41:13 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

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