Australia TGA ARTG record

ACIST Kodama Coronary Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use

Australia TGA ARTG Registered Device · Regional Health Care Group Pty Ltd · Acist Medical Systems Inc · Class III · Started June 09, 2017

Good Name: Regional Health Care Group Pty Ltd - ACIST Kodama Coronary Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: June 09, 2017
Effective Date: June 09, 2017

Sponsor

Name: Regional Health Care Group Pty Ltd

Manufacturer

Name: Acist Medical Systems Inc
Country: United States of America
Address: 7905 Fuller Road, Eden Prairie, MN, 55344

Intended purpose

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.

About this record

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.