Trevo

Main information

  • Trade name:
  • Trevo Pro Microcatheter - Catheter, angiography
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Trevo Pro Microcatheter - Catheter, angiography
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216476
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216476

Stryker Australia Pty Ltd - Trevo Pro 18 Microcatheter - Catheter, angiography

ARTG entry for

Medical Device Included Class III

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

23/10/2013

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

Concentric Medical Inc

301 East Evelyn Avenue

Mountain View, CA, 94041

United States Of America

Products

1. Trevo Pro Microcatheter - Catheter, angiography

Product Type

Single Device Product

Effective date

27/06/2014

GMDN

10688 Catheter, angiography

Functional description

A single lumen, braided shaft, variable stiffness microcatheter with a radiopaque marker on the distal end

and luer hub on the proximal end. Catheter shaft has a hydrophilic coating to reduce friction during use.

Radiopaque shaft and distal marker facilitate fluoroscopic visualization.

Intended purpose

Indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral,

coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

Variant information

Model number (see guidance docs) Trevo Pro 18

Model number (see guidance docs) Trevo Pro 14

Diameter (mm) 0.40-0.50 (inner diameter)

Diameter (mm) 0.66-0.80 (distal tip outer diameter)

Diameter (mm) 0.80-0.90 (proximal outer diameter)

Length (cm) 150-157 (overall length)

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 05:03:48 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