Summary for ARTG Entry:
Abbott Vascular Division of Abbott Australasia Pty Ltd - MINI TREK II OTW Coronary Dilatation Catheter -
Catheter, angioplasty, balloon dilatation
ARTG entry for
Medical Device Included Class III
Abbott Vascular Division of Abbott Australasia Pty Ltd
Locked Bag 2005,North Ryde, NSW, 1670
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.
3200 Lakeside Drive
Santa Clara, CA, 95054
United States Of America
1. MINI TREK II OTW Coronary Dilatation Catheter - Catheter, angioplasty, balloon dilatation
Single Device Product
17184 Catheter, angioplasty, balloon dilatation
These catheters are two-lumen catheters with a balloon near the distal tip. One lumen is used for inflation
of the balloon with contrast medium. The second lumen facilitates advancement of the dilatation catheter
to and through the stenosis to be dilated, and the injection of contrast and/or medication. The balloon
radiopaque marker(s) aid in positioning the balloon in the stenosis. The proximal shaft markers aid in
gauging catheter position relative to the guiding catheter tip.
The MINI TREK II OTW Coronary Dilatation Catheter is indicated for:
· Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the
purpose of improving myocardial perfusion
· Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in
patients with ST-segment elevation myocardial infarction (MI)
· Balloon dilatation of a stent after implantation (balloon models 2.00 mm only)
· Balloon dilatation of de novo chronic total coronary occlusions (CTO)
Length (mm) 6 to 20
Diameter (mm) 1.20 to 2.00
No Specific Conditions included on Record
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