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VARIPULSE™ Bi-Directional Catheter - Cardiac irreversible electroporation system catheter - ARTG 472885

Access comprehensive regulatory information for VARIPULSE™ Bi-Directional Catheter - Cardiac irreversible electroporation system catheter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 472885 and sponsored by Johnson & Johnson Medical Pty Ltd, manufactured by Biosense Webster Inc in United States of America. The device registration started on December 12, 2024.

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
ARTG 472885
Class III
VARIPULSE™ Bi-Directional Catheter - Cardiac irreversible electroporation system catheter
ARTG ID: 472885
Good Name: Johnson & Johnson Medical Pty Ltd - VARIPULSE™ Bi-Directional Catheter - Cardiac irreversible electroporation system catheter
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Intended Purpose

The VARIPULSE™ Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a TRUPULSE™ Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO™ 3 System.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
472885
Start Date
December 12, 2024
Effective Date
December 12, 2024
Manufacturer
Country
United States of America
Address
31 Technology Drive Suite 200, Irvine, California, 92618