Penumbra

Main information

  • Trade name:
  • Penumbra Delivery Microcatheters - Velocity - Intravascular microflow catheter
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Penumbra Delivery Microcatheters - Velocity - Intravascular microflow catheter
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221775
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221775

Penumbra Neuro Australia Pty Ltd - Penumbra Delivery Microcatheters - Velocity - Intravascular microflow

catheter

ARTG entry for

Medical Device Included Class III

Sponsor

Penumbra Neuro Australia Pty Ltd

Postal Address

Suite 3 Level 5 / 1 Oxford Street,DARLINGHURST, NSW, 2010

Australia

ARTG Start Date

28/03/2014

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

Penumbra Inc

One Penumbra Place

Alameda, CA, 94502

United States Of America

Products

1. Penumbra Delivery Microcatheters - Velocity - Intravascular microflow catheter

Product Type

Single Device Product

Effective date

28/03/2014

GMDN

10691 Intravascular microflow catheter

Functional description

The Penumbra Delivery Microcatheters are single lumen medical devices designed to aid a physician in

accessing distal vasculature when using in conjunction with a guide catheter and a micro guidewire.

Penumbra Delivery Microcatheters are supplied with annealed stainless steel mandrels that can be used

to shape the distal tip as desired.

Intended purpose

The Penumbra Delivery Microcatheters are intended to assist in the delivery of diagnostic agents, such as

contrast media, and therapeutic agents, such as occlusion coils to the peripheral and neuro vasculature.

Variant information

Shape (of tip) 130 degree (J)

Shape (of tip) 90 degree

Shape (of tip) Straight

Length (cm) 150 & 160

Shape (of tip) 45 degree

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 09.11.2017 at 11:52:53 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