Australia TGA ARTG record

Tyshak Mini - Catheter, valvuloplasty, balloon dilatation

Australia TGA ARTG Registered Device · Intervene Medical Pty Ltd · Numed Inc · Class III · Started July 27, 2018

Good Name: Intervene Medical Pty Ltd - Tyshak Mini - Catheter, valvuloplasty, balloon dilatation

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 27, 2018
Effective Date: July 27, 2018

Sponsor

Name: Intervene Medical Pty Ltd

Manufacturer

Name: Numed Inc
Country: United States of America
Address: 2880 Main Street, HOPKINTON , New York, 12965

Intended purpose

Percutaneous transluminal valvuplasty of the pulmonary valve in paediatric applications: 1) A patient with isolated pulmonary stenosis, 2) A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

About this record

Access comprehensive regulatory information for Tyshak Mini - Catheter, valvuloplasty, balloon dilatation 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 July 27, 2018.

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.