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Crusade Catheter - Peripheral/coronary vasculature catheter, infusion

Access comprehensive regulatory information for Crusade Catheter - Peripheral/coronary vasculature catheter, infusion in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Bio-Excel Australia Pty Ltd, manufactured by Kaneka Corporation in Japan. The device registration started on June 10, 2011.

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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TGA ARTG Official Data
Class III
Class III
Crusade Catheter - Peripheral/coronary vasculature catheter, infusion
Australia TGA ARTG Registered Device
Good Name: Bio-Excel (Australia) Pty Ltd - Crusade Catheter - Peripheral/coronary vasculature catheter, infusion
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Intended Purpose

The Kaneka Crusade Catheter is a micro catheter intended for use within a guiding catheter in conjuction with a steerable guide wire inserted through the monorail lumen of the Crusade Catheter in order to access discret regions of the vasculature. The main uses of the Crusade catheter are to guide and support a steerable guide wire inserted through its Over-The-Wire lumen (OTW) for guide wire crossing and insertion into a side branch; for guide wire exchange (either monorail or OTW) during Percutaneous Coronary Intervention. It is also used for delivery of a buddy wire (a second coronary guide wire) through the OTW lumen along side the existing one being used to advance balloons and stents inside the coronary arteries to enhance device delivery during Percutaneous Coronary Intervention. In addition, it is also used as an infusion catheter.

Device Classification
Risk Class
Class III
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
June 10, 2011
Effective Date
June 10, 2011
Manufacturer
Country
Japan
Address
3-18 2-Chome Osaka, Osaka, OSAKA, 530-8288