Catheter

Main information

  • Trade name:
  • Catheter, intravascular, guiding
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Catheter, intravascular, guiding
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221049
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221049

Medtronic Australasia Pty Ltd - Catheter, intravascular, guiding

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

12/03/2014

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

Medtronic Inc

710 Medtronic Parkway

Minneapolis, MN, 55432

United States Of America

Products

1. Catheter, intravascular, guiding

Product Type

Single Device Product

Effective date

12/03/2014

GMDN

17846 Catheter, intravascular, guiding

Intended purpose

The TOTAL across™ crossing catheter is intended to guide and support a guidewire, including the

crossing of a target lesion, during the access of peripheral arteries with obstructive disease and to allow for

wire exchanges. The device is also used to provide a conduit for the infusion of saline solutions or

diagnostic contrast agents.

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 02:24:40 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