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WEB Aneurysm Embolization System - Neurovascular embolization coil - ARTG 354834

Access comprehensive regulatory information for WEB Aneurysm Embolization System - Neurovascular embolization coil in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 354834 and sponsored by Culpan Medical Pty Ltd, manufactured by MicroVention Inc in United States of America. The device registration started on February 11, 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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Class III
ARTG 354834
Class III
WEB Aneurysm Embolization System - Neurovascular embolization coil
ARTG ID: 354834
Good Name: Culpan Medical Pty Ltd - WEB Aneurysm Embolization System - Neurovascular embolization coil
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Intended Purpose

The WEB Aneurysm Embolization System is intended for the endovascular embolization of ruptured and unruptured intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae(AVF). The WEB Aneurysm Embolization System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation.The device should only be used by physicians who have undergone appropriate training.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
354834
Start Date
February 11, 2021
Effective Date
November 06, 2023
Manufacturer
Country
United States of America
Address
35 Enterprise, Aliso Viejo, 92656