Summary for ARTG Entry:
William A Cook Australia Pty Ltd - Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach -
Vena cava filter, optional
ARTG entry for
Medical Device Included Class III
William A Cook Australia Pty Ltd
95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113
ARTG Start Date
Medical Device Class III
- 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.
William Cook Europe A/S
, Bjaeverskov, DK 4632
1. Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach - Vena cava filter, optional
Single Device Product
44864 Vena cava filter, optional
The filter is preloaded onto a jugular filter introducer system. The jugular filter introducer system securely
holds on to the retrieval hook and is advanced through an introducer sheath to the intended location.
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
Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.
The product is intended for percutaneous placement via a jugular vein for filtration of inferior vena cava
(IVC) blood to prevent PE.
Nil variant (as 1 device) Nil
No Specific Conditions included on Record
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Produced at 10.11.2017 at 08:03:04 AEDT
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