Cook

Main information

  • Trade name:
  • Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach - Vena cava filter, optional
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach - Vena cava filter, optional
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219276
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219276

William A Cook Australia Pty Ltd - Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein

Approach - Vena cava filter, optional

ARTG entry for

Medical Device Included Class III

Sponsor

William A Cook Australia Pty Ltd

Postal Address

95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

16/01/2014

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

William Cook Europe A/S

Sandet 6

, Bjaeverskov, DK 4632

Denmark

Products

1. Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach - Vena cava filter,

optional

Product Type

Single Device Product

Effective date

16/01/2014

GMDN

44864 Vena cava filter, optional

Functional description

The filter is preloaded onto a femoral filter introducer system or onto a jugular filter introducer system. The

femoral filter introducer system securely fixates the primary legs and is advanced through an introducer

sheath to the intended location. The jugulatr filter introducer system securely holds on to the retrieval hook

and is advanced through an introducer sheath to the intended location.

Intended purpose

The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism

(PE) via placement in the vena cava in the following situations:

Pulmonary thromboembolism when anticoagulant therapy is contraindicated

Failure of anticoagulant therapy in thromboembolic disease

Emergency treatment following massive PE where anticipated benefits of conventional therapy are

reduced

Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior

vena cava (IVC) blood to prevent PE.

Variant information

Nil variant (as 1 device) Nil

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 08:02:48 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

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