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Tyshak NuCLEUS - Catheter, valvuloplasty, balloon dilatation

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.

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Class III
Class III
Tyshak NuCLEUS - Catheter, valvuloplasty, balloon dilatation
Australia TGA ARTG Registered Device
Good Name: Intervene Medical Pty Ltd - Tyshak NuCLEUS - Catheter, valvuloplasty, balloon dilatation
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Intended Purpose

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

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
Manufacturer
Country
Canada
Address
45 Second Street, West Cornwall, Ontario, K6J 1G3