ARTG 399714ViperWire Advance Coronary Guide Wire with Flex tip - Catheter guide wire
ARTG ID: 399714 · 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 - ViperWire Advance Coronary Guide Wire with Flex tip - Catheter guide wire
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 399714
- 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 CSI Diamondback 360 Coronary Orbital Atherectomy System (OAS) is 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. The ViperWire Advance Coronary Guide Wires are intended for use with Diamondback Orbital Atherectomy Device (OAD) and intended use is in adults patients who are 18 years of age and older.
Access comprehensive regulatory information for ViperWire Advance Coronary Guide Wire with Flex tip - Catheter guide wire in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 399714 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.