Australia flagARTG 457892

SureFlex Steerable Guiding Sheath - Catheter, intravascular, guiding

ARTG ID: 457892 · Boston Scientific Pty Ltd · Baylis Medical Company Inc · Class III · Started July 31, 2024

Good Name: Boston Scientific Pty Ltd - SureFlex Steerable Guiding Sheath - Catheter, intravascular, guiding

Device classification
Risk Class
Class III
Product Type
Medical device system
ARTG Category
General
Registration information
ARTG ID
457892
Start Date
July 31, 2024
Effective Date
July 31, 2024
Sponsor
Manufacturer
Country
Canada
Address
5959 Trans-Canada Highway, Montreal, Quebec, H4T 1A1
Intended purpose

For introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

About this record

Access comprehensive regulatory information for SureFlex Steerable Guiding Sheath - Catheter, intravascular, guiding in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 457892 and sponsored by Boston Scientific Pty Ltd, manufactured by Baylis Medical Company Inc in Canada. The device registration started on July 31, 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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