Summary for ARTG Entry:
Abbott Vascular Division of Abbott Australasia Pty Ltd - Traveler RX 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. Traveler RX Coronary Dilatation Catheter - Catheter, angioplasty, balloon dilatation
Single Device Product
17184 Catheter, angioplasty, balloon dilatation
The catheters have an integrated shaft that has a combination of single lumen and dual lumen tubing. 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. The balloon has radiopaque marker(s)
to aid in positioning the balloon in the stenosis. The proximal shaft markers aid in gauging dilatation
catheter position relative to the guiding catheter tip.
Traveler RX Coronary Dilatation Catheters are 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; and balloon dilatation of a stent after implantation (balloon
models 2.00 mm - 5.00 mm only).
Length (mm) 6 ± 30
Diameter (mm) 1.20 ± 5.00
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:19:53 AEDT
This is not an ARTG Certificate document.
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