Pure Global

Tyshak Mini - Catheter, valvuloplasty, balloon dilatation - ARTG 307527

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 registered under ARTG number 307527 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class III
ARTG 307527
Class III
Tyshak Mini - Catheter, valvuloplasty, balloon dilatation
ARTG ID: 307527
Good Name: Intervene Medical Pty Ltd - Tyshak Mini - Catheter, valvuloplasty, balloon dilatation
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
307527
Start Date
July 27, 2018
Effective Date
July 27, 2018
Manufacturer
Country
United States of America
Address
2880 Main Street, HOPKINTON , New York, 12965