Australia TGA ARTG record

Option ELITE Retrievable Vena Cava Filter System - Vena cava filter, optional

Australia TGA ARTG Registered Device · Culpan Medical Pty Ltd · Argon Medical Devices Inc · Class III · Started December 19, 2016

Good Name: Culpan Medical Pty Ltd - Option ELITE Retrievable Vena Cava Filter System - Vena cava filter, optional

Device classification

Risk Class: Class III
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: December 19, 2016
Effective Date: December 19, 2016

Sponsor

Name: Culpan Medical Pty Ltd

Manufacturer

Name: Argon Medical Devices Inc
Country: United States of America
Address: 1445 Flat Creek Road, Athens, Texas, 75751

Intended purpose

Indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: - Pulmonary thromboembolism when anticoagulants are contraindicated - Failure of anticoagulant therapy in thromboembolic disease - Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated The Filter may be removed according to supplied instructions in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

About this record

Access comprehensive regulatory information for Option ELITE Retrievable Vena Cava Filter System - Vena cava filter, optional in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Culpan Medical Pty Ltd, manufactured by Argon Medical Devices Inc in United States of America. The device registration started on December 19, 2016.

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.