Embolectomy thrombectomy

Main information

  • Trade name:
  • Embolectomy/thrombectomy balloon catheter
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Embolectomy/thrombectomy balloon catheter
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220789
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220789

Applied Medical Australia Pty Ltd - Embolectomy/thrombectomy balloon catheter

ARTG entry for

Medical Device Included Class IIa

Sponsor

Applied Medical Australia Pty Ltd

Postal Address

PO Box 1545,STAFFORD CITY, QLD, 4053

Australia

ARTG Start Date

6/03/2014

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

Applied Medical Resources

22872 Avenida Empressa

Rancho Santa Margarita, California, 92688

United States Of America

Products

1. Embolectomy/thrombectomy balloon catheter

Product Type

Single Device Product

Effective date

6/03/2014

GMDN

58174 Embolectomy/thrombectomy balloon catheter

Intended purpose

Python catheters are indicated for removal of thromboemboli from the peripheral arterial system and for

occlusion and infusion of fluids into a vessel.

Embolectomy catheters are indicated for the removal of emboli and thrombi from the peripheral arterial

system.

Thrombectomy catheters are indicated for use in vascular grafts and peripheral venous thrombectomy

procedures.

The Over-the-Wire latis Graft Cleaning Catheter is indicated for the removal of thromboemboli from

vascular grafts and for occlusion and infusion of fluids into a graft.

The latis catheter is indicated for the removal of thrombus from peripheral vascular grafts.

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 03:06:53 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