Australia flagARTG 468765

Swan-Ganz IQ Pulmonary Arterial Catheter - Catheter, cardiac, balloon, thermal dilution

ARTG ID: 468765 · Edwards Lifesciences Pty Ltd · Edwards Lifesciences LLC · Class III · Started November 14, 2024

Good Name: Edwards Lifesciences Pty Ltd - Swan-Ganz IQ Pulmonary Arterial Catheter - Catheter, cardiac, balloon, thermal dilution

Device classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
468765
Start Date
November 14, 2024
Effective Date
November 14, 2024
Sponsor
Manufacturer
Country
United States of America
Address
One Edwards Way, Irvine, California, 92614
Intended purpose

The Swan-Ganz IQ catheter is a pulmonary artery catheter intended for short-term use in the central circulatory system for patients who require intracardiac hemodynamic monitoring, blood sampling and infusing solutions. When used with a compatible monitoring platform and accessories, the Swan-Ganz IQ catheter offers a comprehensive hemodynamic profile to help clinicians assess cardiovascular function and guide treatment decisions.

About this record

Access comprehensive regulatory information for Swan-Ganz IQ Pulmonary Arterial Catheter - Catheter, cardiac, balloon, thermal dilution in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 468765 and sponsored by Edwards Lifesciences Pty Ltd, manufactured by Edwards Lifesciences LLC in United States of America. The device registration started on November 14, 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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