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Agilis™ NxT Steerable Introducer Dual-Reach™ - Epicardial guide-catheter - ARTG 483205

Access comprehensive regulatory information for Agilis™ NxT Steerable Introducer Dual-Reach™ - Epicardial guide-catheter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 483205 and sponsored by Abbott Medical Australia Pty Ltd, manufactured by Abbott Medical in United States of America. The device registration started on March 19, 2025.

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 III
ARTG 483205
Class III
Agilis™ NxT Steerable Introducer Dual-Reach™ - Epicardial guide-catheter
ARTG ID: 483205
Good Name: Abbott Medical Australia Pty Ltd - Agilis™ NxT Steerable Introducer Dual-Reach™ - Epicardial guide-catheter
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Intended Purpose

The Agilis™ NxT Steerable Introducer Dual-Reach™ is intended to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
483205
Start Date
March 19, 2025
Effective Date
March 19, 2025
Manufacturer
Country
United States of America
Address
14901 DeVeau Place, Minnetonka, Minnesota, 55345