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Catheter, intravascular, guiding - ARTG 408972

Access comprehensive regulatory information for Catheter, intravascular, guiding in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 408972 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Oscor Incorporated in United States of America. The device registration started on May 15, 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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TGA ARTG Official Data
Class I
ARTG 408972
Class I
Catheter, intravascular, guiding
ARTG ID: 408972
Good Name: Medtronic Australasia Pty Ltd - Catheter, intravascular, guiding
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Intended Purpose

The steerable sheath, model TourGuide is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
ARTG ID
408972
Start Date
May 15, 2023
Effective Date
May 15, 2023
Manufacturer
Country
United States of America
Address
3816 DeSoto Blvd, PALM HARBOR, Florida, 34683