ARTG 405210Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit
ARTG ID: 405210 · Mainstay Medical Australia Pty Ltd · Oscor Incorporated · Class III · Started February 21, 2023
Good Name: Mainstay Medical Australia Pty Ltd - Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 405210
- Start Date
- February 21, 2023
- Effective Date
- February 21, 2023
- Country
- United States of America
- Address
- 3816 DeSoto Blvd, PALM HARBOR, Florida, 34683
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.
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 registered under ARTG number 405210 and 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.