Adroit

Main information

  • Trade name:
  • Adroit Guiding Catheter - Catheter, intravascular, guiding
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Adroit Guiding Catheter - Catheter, intravascular, guiding
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219052
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219052

Cardinal Health Australia 503 Pty Ltd - Adroit Guiding Catheter - Catheter, intravascular, guiding

ARTG entry for

Medical Device Included Class III

Sponsor

Cardinal Health Australia 503 Pty Ltd

Postal Address

Level 5 - 7 Eden Park Drive,North Ryde, NSW, 2113

Australia

ARTG Start Date

9/01/2014

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

Cordis Corp

14201 North-West 60th Avenue

Miami Lakes, Florida, 33014

United States Of America

Products

1. Adroit Guiding Catheter - Catheter, intravascular, guiding

Product Type

Single Device Product

Effective date

24/12/2015

GMDN

17846 Catheter, intravascular, guiding

Functional description

Facilitates the intravascular passage and positioning of interventional/diagnostic devices.

Intended purpose

The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices

into the coronary or peripheral vascular system.

Variant information

Shape (of tip) J-Curve Visceral

Shape (of tip) Cerebral Modified Burke

Shape (of tip) Multipurpose

Shape (of tip) Hockey Stick

Shape (of tip) Straight

Shape (of tip) Radial Bi-Lateral

Shape (of tip) 3D LIMA 90 Degree

Shape (of tip) Brachial Left

Shape (of tip) Renal Curve (small)

Shape (of tip) Judkins

Shape (of tip) Extra Back-up

Shape (of tip) Judkins Curved Left

Length (cm) 55

Shape (of tip) Fajadet

Shape (of tip) RDC (Large)

Shape (of tip) RDC (small)

Shape (of tip) Internal Mammary

Shape (of tip) Amplatz

Shape (of tip) El Gamal

Shape (of tip) Coronary Bypass

Shape (of tip) RRAD5 (Right Radial)

Guage (French) 5, 6

Shape (of tip) Judkins Curved Right

Length (cm) 125

Length (cm) 100

Length (cm) 90

Shape (of tip) Noto

Shape (of tip) DRC

Shape (of tip) Radial Brachial

Shape (of tip) Barbeau

Public Summary

Page 1 of

Produced at 10.11.2017 at 08:33:41 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

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 10.11.2017 at 08:33:41 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