Australia TGA ARTG record

Emboli capture guidewire

Australia TGA ARTG Registered Device · Bio-Excel Australia Pty Ltd · Cardiovascular Systems Inc · Class IIa · Started August 04, 2021

Good Name: Bio-Excel Australia Pty Ltd - Emboli capture guidewire

Device classification

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

Registration information

Start Date: August 04, 2021
Effective Date: August 04, 2021

Sponsor

Name: Bio-Excel Australia Pty Ltd

Manufacturer

Name: Cardiovascular Systems Inc
Country: United States of America
Address: 1225 Old Highway 8 NW, Saint Paul, MN, 55112

Intended purpose

WIRION is indicated for use as an embolic protection system to contain and remove embolic material(thrombus/debris)while performing lower extremity peripheral vascular arterial intervention procedures. The diameter of the vessel at the site of filter basket placement should be between 3.5 to 6.0 mm. WIRION may be used with commercially available 0.014" guide wires.

About this record

Access comprehensive regulatory information for Emboli capture guidewire in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Bio-Excel Australia Pty Ltd, manufactured by Cardiovascular Systems Inc in United States of America. The device registration started on August 04, 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.