Summary for ARTG Entry:
William A Cook Australia Pty Ltd - Curved 16Fr. Introducer Set - Femoral - Fascial tissue dilator, single-use
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. Curved 16Fr. Introducer Set - Femoral - Fascial tissue dilator, single-use
Single Device Product
46448 Fascial tissue dilator, single-use
The 16Fr Curved Femoral Sheath Set is designed to add directional control to the Femoral Helical Loop
Basket/Tip Deflecting Wire Guide combination or to the Needle's Eye Snare. The indwelling object is
prepared for removal by advancing the 16Fr Curved Sheath over the object until the object enters the 16Fr
This device is for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads,
fragments of catheter tubing or wire guides and other foreign objects.
Nil variant (as 1 device) Nil
No Specific Conditions included on Record
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Produced at 10.11.2017 at 10:01:52 AEDT
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