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ViperWire Advance Coronary Guide Wire with Flex tip - Catheter guide wire

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 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.

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Class III
Class III
ViperWire Advance Coronary Guide Wire with Flex tip - Catheter guide wire
Australia TGA ARTG Registered Device
Good Name: Abbott Vascular Division of Abbott Medical Australia Pty Ltd - ViperWire Advance Coronary Guide Wire with Flex tip - Catheter guide wire
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Intended Purpose

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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 21, 2022
Effective Date
November 21, 2022
Manufacturer
Country
United States of America
Address
1225 Old Highway 8 NW, Saint Paul, MN, 55112