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Z-6 Atrioseptostomy Catheter - Catheter, septostomy

Access comprehensive regulatory information for Z-6 Atrioseptostomy Catheter - Catheter, septostomy in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Intervene Medical Pty Ltd, manufactured by Numed Inc in United States of America. The device registration started on October 05, 2023.

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
Z-6 Atrioseptostomy Catheter - Catheter, septostomy
Australia TGA ARTG Registered Device
Good Name: Intervene Medical Pty Ltd - Z-6 Atrioseptostomy Catheter - Catheter, septostomy
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Intended Purpose

Device used for balloon atrioseptostomy - for the palliation of several congenital cardiac defects in conjunction with diagnostic cardiac catheterization. Atrioseptostomy can be carried out after the diagnosis of several congenital cardiac defects including: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 05, 2023
Effective Date
October 05, 2023
Manufacturer
Country
United States of America
Address
2880 Main Street, HOPKINTON , New York, 12965