Australia flagARTG 460504

VersaCross Access Solution - Transseptal access system

ARTG ID: 460504 · Boston Scientific Pty Ltd · Baylis Medical Company Inc · Class III · Started August 23, 2024

Good Name: Boston Scientific Pty Ltd - VersaCross Access Solution - Transseptal access system

Device classification
Risk Class
Class III
Product Type
Medical device system
ARTG Category
General
Registration information
ARTG ID
460504
Start Date
August 23, 2024
Effective Date
August 23, 2024
Sponsor
Manufacturer
Country
Canada
Address
5959 Trans-Canada Highway, Montreal, Quebec, H4T 1A1
Intended purpose

The VersaCross Access Solution is indicated for creation of an atrial septal defect in the heart and for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation/puncture.

About this record

Access comprehensive regulatory information for VersaCross 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 460504 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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