Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - Catheter, intravascular, guiding
ARTG entry for
Medical Device Included Class IIa
Medtronic Australasia Pty Ltd
PO Box 945,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class IIa
- 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.
710 Medtronic Parkway
Minneapolis, MN, 55432
United States Of America
1. Catheter, intravascular, guiding
Single Device Product
17846 Catheter, intravascular, guiding
The TOTAL across™ crossing catheter is intended to guide and support a guidewire, including the
crossing of a target lesion, during the access of peripheral arteries with obstructive disease and to allow for
wire exchanges. The device is also used to provide a conduit for the infusion of saline solutions or
diagnostic contrast agents.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 02:24:40 AEDT
This is not an ARTG Certificate document.
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