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Emboli capture guidewire

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.

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Class IIa
Class IIa
Emboli capture guidewire
Australia TGA ARTG Registered Device
Good Name: Bio-Excel Australia Pty Ltd - Emboli capture guidewire
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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.

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
Manufacturer
Country
United States of America
Address
1225 Old Highway 8 NW, Saint Paul, MN, 55112