Australia flagARTG 463985

Aptus TourGuide Steerable Guiding Sheath - Catheter, intravascular, guiding

ARTG ID: 463985 · Medtronic Australasia Pty Ltd · Oscor Incorporated · Class III · Started October 09, 2024

Good Name: Medtronic Australasia Pty Ltd - Aptus TourGuide Steerable Guiding Sheath - Catheter, intravascular, guiding

Device classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
463985
Start Date
October 09, 2024
Effective Date
October 09, 2024
Sponsor
Manufacturer
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 or other peripheral placements. Do not use this device for neural placements.

About this record

Access comprehensive regulatory information for Aptus TourGuide Steerable Guiding Sheath - Catheter, intravascular, guiding in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 463985 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Oscor Incorporated in United States of America. The device registration started on October 09, 2024.

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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