Australia TGA ARTG record

Headway Duo Microcatheter - Catheter, intravascular, guiding

Australia TGA ARTG Registered Device · Culpan Medical Pty Ltd · MicroVention Inc · Class III · Started November 15, 2017

Good Name: Culpan Medical Pty Ltd - Headway Duo Microcatheter - Catheter, intravascular, guiding

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: November 15, 2017
Effective Date: November 15, 2017

Sponsor

Name: Culpan Medical Pty Ltd

Manufacturer

Name: MicroVention Inc
Country: United States of America
Address: 35 Enterprise, Aliso Viejo, 92656

Intended purpose

The Headway Duo Microcatheter is intended for general intravascular use, including the peripheral and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials. The Headway Duo Microcatheter is intended for neurovascular use, for the infusion of diagnostic agents, such as contrast media, and therapeutic agents that have been cleared or approved for use in the neurovasculature and are compatible with the inner diameter of the Headway Duo Microcatheter.

About this record

Access comprehensive regulatory information for Headway Duo Microcatheter - Catheter, intravascular, guiding 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 MicroVention Inc in United States of America. The device registration started on November 15, 2017.

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.