Main information

  • Trade name:
  • Neuron MAX Long Sheath - Catheter, intravascular, guiding
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Neuron MAX Long Sheath - Catheter, intravascular, guiding
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216374
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Penumbra Neuro Australia Pty Ltd - Neuron MAX Long Sheath - Catheter, intravascular, guiding

ARTG entry for

Medical Device Included Class III


Penumbra Neuro Australia Pty Ltd

Postal Address

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


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Penumbra Inc

One Penumbra Place

Alameda, CA, 94502

United States Of America


1. Neuron MAX Long Sheath - Catheter, intravascular, guiding

Product Type

Single Device Product

Effective date



17846 Catheter, intravascular, guiding

Functional description

The Neuron MAX Long Sheath consists of the Neuron MAX Delivery Catheter and accessories.The

Neuron MAX Delivery Catheter is a single lumen, braid-reinforced, variable stiffness catheter with a

radiopaque zone on the distal end and a Luer hub on the proximal end. The Neuron MAX Delivery

Catheter is compatible with introducer sheaths appropriately sized for the outer diameter of Neuron MAX.

Intended purpose

The Neuron MAX System is indicated for the introduction of interventional devices into the peripheral,

coronary, and neuro vasculature.

Variant information

Length (cm) 80

Length (cm) 90

Shape (of tip) Multi-Purpose Shape

Length (cm) 70

Length (cm) 100

Shape (of tip) Straight

Specific Conditions

No Specific Conditions included on Record

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written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 10.11.2017 at 05:13:01 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.

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