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VersaCross Steerable Access Solution - Transseptal access system - ARTG 460505

Access comprehensive regulatory information for VersaCross Steerable Access Solution - Transseptal access system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 460505 and sponsored by Boston Scientific Pty Ltd, manufactured by Baylis Medical Company Inc in Canada. The device registration started on August 23, 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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Class III
ARTG 460505
Class III
VersaCross Steerable Access Solution - Transseptal access system
ARTG ID: 460505
Good Name: Boston Scientific Pty Ltd - VersaCross Steerable Access Solution - Transseptal access system
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Intended Purpose

The VersaCross Steerable Access Solution is indicated for creation of an atrial septal defect in the heart and for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum

Device Classification
Risk Class
Class III
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
460505
Start Date
August 23, 2024
Effective Date
August 23, 2024
Manufacturer
Country
Canada
Address
5959 Trans-Canada Highway, Montreal, Quebec, H4T 1A1