Summary for ARTG Entry:
Boston Scientific Pty Ltd - OptiCross Coronary Imaging Catheter - Transducer assembly, ultrasound,
diagnostic, intracorporeal, intravascular
ARTG entry for
Medical Device Included Class III
Boston Scientific Pty Ltd
PO Box 332,BOTANY, NSW, 1455
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.
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA, 01752
United States Of America
1. OptiCross Coronary Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal,
37895 Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular
OptiCross Catheter consists of Imaging Core composed of drive cable with ultrasonic transducer at distal
tip and proximal end of catheter connection to motordrive unit.
Catheter body with distal imaging window lumen & proximal exit at distal end. Proximal shaft lumen with
markers to aid in catheter positioning is attached to telescoping section that has proximal markers for
lesion length assessment.
This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular
ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional
The Catheter is packaged with a Sterile Bag, extension tube, 3 cm3 (cc) and 10 cm3 (cc) syringes and a
Nil variant (as 1 device) N/A
No Specific Conditions included on Record
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