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Introducer Kit For Impella - Vascular introducer kit - ARTG 368070

Access comprehensive regulatory information for Introducer Kit For Impella - 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 368070 and sponsored by Abiomed Australia Pty Ltd, manufactured by Oscor Incorporated in United States of America. The device registration started on June 03, 2021.

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 III
ARTG 368070
Class III
Introducer Kit For Impella - Vascular introducer kit
ARTG ID: 368070
Good Name: Abiomed Australia Pty Ltd - Introducer Kit For Impella - Vascular introducer kit
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Intended Purpose

The Introducer Kit for Impella is intended to allow access via the femoral artery for insertion of catheters and pacing leads including the Impella series of ventricular assist devices.

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
368070
Start Date
June 03, 2021
Effective Date
June 03, 2021
Manufacturer
Country
United States of America
Address
3816 DeSoto Blvd, PALM HARBOR, Florida, 34683