Australia TGA ARTG record

Tyshak NuCLEUS - Catheter, valvuloplasty, balloon dilatation

Australia TGA ARTG Registered Device · Intervene Medical Pty Ltd · Numed Canada Inc · Class III · Started December 13, 2016

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

Device classification

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

Registration information

Start Date: December 13, 2016
Effective Date: December 13, 2016

Sponsor

Name: Intervene Medical Pty Ltd

Manufacturer

Name: Numed Canada Inc
Country: Canada
Address: 45 Second Street, West Cornwall, Ontario, K6J 1G3

Intended purpose

For Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in patients where the patient has: • An isolated pulmonary stenosis. • Valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention

About this record

Access comprehensive regulatory information for Tyshak NuCLEUS - 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 Canada Inc in Canada. The device registration started on December 13, 2016.

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.