Australia TGA ARTG record

Vascular introducer kit

Australia TGA ARTG Registered Device · Biotronik Australia Pty Ltd · Galt Medical Corp · Class IIa · Started March 24, 2022

Good Name: Biotronik Australia Pty Ltd - Vascular introducer kit

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: March 24, 2022
Effective Date: March 24, 2022

Sponsor

Name: Biotronik Australia Pty Ltd

Manufacturer

Name: Galt Medical Corp
Country: United States of America
Address: 2220 Merritt Drive, Garland, TX, 75041

Intended purpose

These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

About this record

Access comprehensive regulatory information for Vascular introducer kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Biotronik Australia Pty Ltd, manufactured by Galt Medical Corp in United States of America. The device registration started on March 24, 2022.

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.