ARTG 399713Diamondback 360 Coronary Orbital Atherectomy Device - Mechanical atherectomy system, coronary, line-powered
ARTG ID: 399713 · Abbott Vascular Division of Abbott Medical Australia Pty Ltd · Cardiovascular Systems Inc · Class III · Started November 21, 2022
Good Name: Abbott Vascular Division of Abbott Medical Australia Pty Ltd - Diamondback 360 Coronary Orbital Atherectomy Device - Mechanical atherectomy system, coronary, line-powered
- Risk Class
- Class III
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 399713
- Start Date
- November 21, 2022
- Effective Date
- November 21, 2022
- Country
- United States of America
- Address
- 1225 Old Highway 8 NW, Saint Paul, MN, 55112
The Diamondback 360 Coronary Orbital Atherectomy Device Classic (OAD)is a component of the Diamondback 360 Coronary Orbital Atherectomy System (OAS), a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. OAD consists of the Diamond-coated crown, Drive shaft, Saline shealth, Physician-operated handle, Power supply cable that connects to the OAS Pump and Saline port connector for the saline line.
Access comprehensive regulatory information for Diamondback 360 Coronary Orbital Atherectomy Device - Mechanical atherectomy system, coronary, line-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 399713 and sponsored by Abbott Vascular Division of Abbott Medical Australia Pty Ltd, manufactured by Cardiovascular Systems Inc in United States of America. The device registration started on November 21, 2022.
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.