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Vibratory intravascular recanalization system saline injector - ARTG 332920

Access comprehensive regulatory information for Vibratory intravascular recanalization system saline injector in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 332920 and sponsored by Abbott Vascular Division of Abbott Medical Australia Pty Ltd, manufactured by Cardiovascular Systems Inc in United States of America. The device registration started on March 31, 2020.

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 332920
Class IIb
Vibratory intravascular recanalization system saline injector
ARTG ID: 332920
Good Name: Abbott Vascular Division of Abbott Medical Australia Pty Ltd - Vibratory intravascular recanalization system saline injector
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Intended Purpose

The OAS pump provides the saline/lubricant pumping mechanism and power to the device. The small, reusable, and portable OAS pump attaches to a standard five wheel rolling intravenous (IV) pole and plugs in to a wall power outlet. The OAS pump includes a built-in, audible 25 second spin time notification, system power and priming buttons, and status indicators.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
332920
Start Date
March 31, 2020
Effective Date
March 31, 2020
Manufacturer
Country
United States of America
Address
1225 Old Highway 8 NW, Saint Paul, MN, 55112