DualproTM IVUS+NIRS Imaging Catheter or Dualpro Catheter - Transducer assembly; ultrasound; diagnostic; intracorporeal; intravascular; single-use - ARTG 409542
Access comprehensive regulatory information for DualproTM IVUS+NIRS Imaging Catheter or Dualpro Catheter - Transducer assembly; ultrasound; diagnostic; intracorporeal; intravascular; single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 409542 and sponsored by Nipro Australia Pty Ltd, manufactured by Infraredex Inc in United States of America. The device registration started on May 24, 2023.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The DualproTM IVUS+NIRS Imaging Catheter is a single use, disposable coronary catheter designed for use with the Infraredx MakotoTM IVUS+NIRS Imaging System, TVC-MC10 and TVC-MC10i models. The Makoto IVUS+NIRS Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest and the assessment of coronary artery lipid core burden. The System is intended for identification of patients and plaques at increased risk of major adverse cardiac events. The System is intended for ultrasound examination of coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.