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9F Acuity Pro Guide Catheter - Catheter, intravascular, guiding

Access comprehensive regulatory information for 9F Acuity Pro Guide Catheter - Catheter, intravascular, guiding in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Boston Scientific Pty Ltd, manufactured by Cardiac Pacemakers Inc a subsidiary of Boston Scientific Corporation in United States of America. The device registration started on July 10, 2024.

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
9F Acuity Pro Guide Catheter - Catheter, intravascular, guiding
Australia TGA ARTG Registered Device
Good Name: Boston Scientific Pty Ltd - 9F Acuity Pro Guide Catheter - Catheter, intravascular, guiding
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Intended Purpose

The ACUITY Pro Lead Delivery System is intended to access the coronary venous system. The ACUITY Pro 9F Guide Catheter serves as a conduit for the delivery of contrast medium and devices, including implantable Boston Scientific coronary venous leads, introduced into the coronary venous system. The guide catheter may be used alone (9F) or in dual catheter delivery (9F with 7F).

Device Classification
Risk Class
Class III
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 10, 2024
Effective Date
July 10, 2024
Manufacturer
Country
United States of America
Address
4100 Hamline Avenue North, St Paul, Minnesota, 55112-5798