Summary for ARTG Entry:
William A Cook Australia Pty Ltd - SteadySheath Evolution Tissue Stabilization Sheath Set - Fascial tissue
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.
750 Daniels Way
Bloomington, Indiana, 47404
United States Of America
1. SteadySheath Evolution Tissue Stabilization Sheath Set - Fascial tissue dilator, single-use
Single Device Product
46448 Fascial tissue dilator, single-use
The SteadySheath™ Evolution® Tissue Stabilization Sheath is provided for use in situations where
enhanced sheath tip visibility and/or tissue stabilization is desired. In its role as an Evolution outer sheath,
the SteadySheath works in together with the inner Evolution braided inner sheath to assist in the removal
of cardiac leads or related catheters by bypassing and/or disrupting transvenous binding scar tissue.
This device is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac
leads, indwelling catheters and foreign objects.
Guage (French) Sheath Size (I.D.) 9-13 (3 sizes in
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:28:04 AEDT
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