ACIST Kodama Coronary Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use
Access comprehensive regulatory information for ACIST Kodama Coronary Imaging 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 sponsored by Regional Health Care Group Pty Ltd, manufactured by Acist Medical Systems Inc in United States of America. The device registration started on June 09, 2017.
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 Kodama intravascular ultrasound catheter is a medical device for use by or on the order of a physician and is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.