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Vascular introducer kit - ARTG 386230

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 registered under ARTG number 386230 and 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.

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TGA ARTG Official Data
Class IIa
ARTG 386230
Class IIa
Vascular introducer kit
ARTG ID: 386230
Good Name: Biotronik Australia Pty Ltd - Vascular introducer kit
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Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
386230
Start Date
March 24, 2022
Effective Date
March 24, 2022
Manufacturer
Country
United States of America
Address
2220 Merritt Drive, Garland, TX, 75041