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Vascular introducer kit

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 I is sponsored by Biotronik Australia Pty Ltd, manufactured by Oscor Incorporated in United States of America. The device registration started on January 09, 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
Class I
Vascular introducer kit
Australia TGA ARTG Registered Device
Good Name: Biotronik Australia Pty Ltd - Vascular introducer kit
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Intended Purpose

Adelante Peel-Away Introducer Set is intended for introduction of pacing leads or catheters into the body.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
Start Date
January 09, 2023
Effective Date
January 09, 2023
Manufacturer
Country
United States of America
Address
3816 DeSoto Blvd, PALM HARBOR, Florida, 34683