Australia TGA ARTG record

Catheter, intravascular, guiding

Australia TGA ARTG Registered Device · Medtronic Australasia Pty Ltd · Oscor Incorporated · Class I · Started May 15, 2023

Good Name: Medtronic Australasia Pty Ltd - Catheter, intravascular, guiding

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General-Export

Registration information

Start Date: May 15, 2023
Effective Date: May 15, 2023

Sponsor

Name: Medtronic Australasia Pty Ltd

Manufacturer

Name: Oscor Incorporated
Country: United States of America
Address: 3816 DeSoto Blvd, PALM HARBOR, Florida, 34683

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.

About this record

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 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.