Australia TGA ARTG record

Lutonix 014 Drug Coated Balloon PTA Catheter Model 9005 - Peripheral angioplasty balloon catheter, drug-eluting

Australia TGA ARTG Registered Device · Bard Australia Pty Ltd · Bard Peripheral Vascular Inc · Class III · Started January 03, 2024

Good Name: Bard Australia Pty Ltd - Lutonix 014 Drug Coated Balloon PTA Catheter Model 9005 - Peripheral angioplasty balloon catheter, drug-eluting

Device classification

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

Registration information

Start Date: January 03, 2024
Effective Date: January 03, 2024

Sponsor

Name: Bard Australia Pty Ltd

Manufacturer

Name: Bard Peripheral Vascular Inc
Country: United States of America
Address: 1625 West 3rd Street, Tempe, AZ, 85281

Intended purpose

The Lutonix™ 014 Drug Coated Balloon Catheter is intended for use as a PTA catheter to dilate stenotic or obstructive vascular lesions in the popliteal and infra-popliteal arteries, for the purpose of improving limb perfusion and decreasing the incidence of restenosis.

About this record

Access comprehensive regulatory information for Lutonix 014 Drug Coated Balloon PTA Catheter Model 9005 - Peripheral angioplasty balloon catheter, drug-eluting in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Bard Australia Pty Ltd, manufactured by Bard Peripheral Vascular Inc in United States of America. The device registration started on January 03, 2024.

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.