ØFTLC

Main information

  • Trade name:
  • ØFTLC braided angiography catheters - Catheter, angiography
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • ØFTLC braided angiography catheters - Catheter, angiography
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220511
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220511

N Stenning & Co Pty Ltd - øFTLC braided angiography catheters - Catheter, angiography

ARTG entry for

Medical Device Included Class III

Sponsor

Getz Healthcare Pty Ltd

Postal Address

5 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

26/02/2014

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

Balt Extrusion

10 Rue de la Croix-Vigneron

MONTMORENCY, , 95160

France

Products

1. øFTLC braided angiography catheters - Catheter, angiography

Product Type

Single Device Product

Effective date

26/02/2014

GMDN

10688 Catheter, angiography

Functional description

Braided angiography catheters use the reference øFTLC. This corresponds to : ø (diameter in french unit)

+ T + L (length in cm) + C (the name of the curve). Braided catheters have stainless steel mesh

reinforcement in the plastic matrix and a supple distal tip. Angiographic catheters are designed for

selective catheterisation of concerned vessels. The different lengths and sizes allow adaptability to each

situation. Angiographic catheters are radio-opaque.

Intended purpose

Angiographic catheters are designed for selective or global angiographic examinations and therapeutic

embolisations.

Variant information

Shape (of tip) Headhunter

Shape (of tip) Gensini

Shape (of tip) Cerebral 6

Shape (of tip) Cerebral 10

Shape (of tip) Left Carotide I

Shape (of tip) Cobra II

Shape (of tip) Cobra I

Shape (of tip) Bentson II

Length (cm) 30 - 145

Guage (French) 5 to 6

Shape (of tip) Cobra III

Shape (of tip) Femoral Renal

Shape (of tip) Left Spermatic Angiography

Shape (of tip) Right Spermatic Angiography

Shape (of tip) Peggy Cath Simmons II

Shape (of tip) Kassel II

Shape (of tip) Vertebral 15

Shape (of tip) Valavanis

Shape (of tip) Multipurposes

Shape (of tip) Tonnelier 7

Shape (of tip) Tonnelier 13

Shape (of tip) Tonnelier 10

Shape (of tip) Simmons III

Shape (of tip) Simmons II

Shape (of tip) Simmons I

Shape (of tip) Medullaire III

Shape (of tip) Medullaire II

Public Summary

Page 1 of

Produced at 01.12.2017 at 06:14:34 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

Shape (of tip) Medullaire I

Shape (of tip) Left Judkins 35

Shape (of tip) Right Judkins 35

Shape (of tip) Headhunter III

Shape (of tip) Headhunter II

Shape (of tip) Headhunter I

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 2 of

Produced at 01.12.2017 at 06:14:34 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