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Vibratory intravascular recanalization system generator - ARTG 399639

Access comprehensive regulatory information for Vibratory intravascular recanalization system generator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 399639 and sponsored by Bard Australia Pty Ltd, manufactured by Bard Peripheral Vascular Inc in United States of America. The device registration started on November 18, 2022.

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 IIb
ARTG 399639
Class IIb
Vibratory intravascular recanalization system generator
ARTG ID: 399639
Good Name: Bard Australia Pty Ltd - Vibratory intravascular recanalization system generator
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Intended Purpose

Used in combination with the Ultrasonic CTO Device to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
399639
Start Date
November 18, 2022
Effective Date
November 18, 2022
Manufacturer
Country
United States of America
Address
1625 West 3rd Street, Tempe, AZ, 85281