Zurpaz

Main information

  • Trade name:
  • Zurpaz Steerable Sheath - Cardiovascular device introducer, steerable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Zurpaz Steerable Sheath - Cardiovascular device introducer, steerable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221754
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221754

Boston Scientific Pty Ltd - Zurpaz Steerable Sheath - Cardiovascular device introducer, steerable

ARTG entry for

Medical Device Included Class III

Sponsor

Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455

Australia

ARTG Start Date

27/03/2014

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

Creganna Medical

Parkmore West

, Galway,

Ireland

Products

1. Zurpaz Steerable Sheath - Cardiovascular device introducer, steerable

Product Type

Single Device Product

Effective date

27/03/2014

GMDN

57968 Cardiovascular device introducer, steerable

Functional description

The steerable sheath set is designed to provide flexible catheter positioning in the cardiac anatomy. It is

fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A

sideport with 3-way stopcock is provided for air/blood aspiration, fluid infusion, blood sampling and

pressure monitoring. The handle is equipped with a rotating knob to deflect the tip clockwise ? 180° and

counterclockwise ? 90°.

Intended purpose

Indicated for use when introducing various cardiovascular catheters into the heart, including the left side of

the heart through the interatrial septum.

Variant information

Shape Asymmetric

Shape Symmetric

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 11:56:16 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