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BOBBY Balloon Guide Catheter - Catheter, intravascular, occluding

Access comprehensive regulatory information for BOBBY Balloon Guide Catheter - Catheter, intravascular, occluding in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Life Healthcare Pty Ltd, manufactured by MicroVention Inc in United States of America. The device registration started on October 05, 2023.

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
BOBBY Balloon Guide Catheter - Catheter, intravascular, occluding
Australia TGA ARTG Registered Device
Good Name: Life Healthcare Pty Ltd - BOBBY Balloon Guide Catheter - Catheter, intravascular, occluding
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Intended Purpose

The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also intended for use as a conduit for retrieval devices.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 05, 2023
Effective Date
October 05, 2023
Manufacturer
Country
United States of America
Address
1311 Valencia Avenue, Tustin, CA, 92780