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Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit

Access comprehensive regulatory information for Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Mainstay Medical Australia Pty Ltd, manufactured by Oscor Incorporated in United States of America. The device registration started on February 21, 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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Class III
Class III
Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit
Australia TGA ARTG Registered Device
Good Name: Mainstay Medical Australia Pty Ltd - Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit
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Intended Purpose

The Adelante Peel Away Introducer System is intended for the introduction of pacing leads or catheters into the body. It is sterile and single use.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 21, 2023
Effective Date
February 21, 2023
Manufacturer
Country
United States of America
Address
3816 DeSoto Blvd, PALM HARBOR, Florida, 34683