Australia TGA ARTG record

BOBBY Balloon Guide Catheter - Catheter, intravascular, occluding

Australia TGA ARTG Registered Device · Life Healthcare Pty Ltd · MicroVention Inc · Class III · Started October 05, 2023

Good Name: Life Healthcare Pty Ltd - BOBBY Balloon Guide Catheter - Catheter, intravascular, occluding

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

Sponsor

Name: Life Healthcare Pty Ltd

Manufacturer

Name: MicroVention Inc
Country: United States of America
Address: 1311 Valencia Avenue, Tustin, CA, 92780

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.

About this record

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.