Australia TGA ARTG record

Thrombectomy rotational catheter

Australia TGA ARTG Registered Device · Culpan Medical Pty Ltd · Argon Medical Devices Inc · Class IIb · Started July 14, 2016

Good Name: Culpan Medical Pty Ltd - Thrombectomy rotational catheter

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 14, 2016
Effective Date: July 14, 2016

Sponsor

Name: Culpan Medical Pty Ltd

Manufacturer

Name: Argon Medical Devices Inc
Country: United States of America
Address: 1445 Flat Creek Road, Athens, Texas, 75751

Intended purpose

Intended to be used for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts and for the controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature.

About this record

Access comprehensive regulatory information for Thrombectomy rotational catheter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Culpan Medical Pty Ltd, manufactured by Argon Medical Devices Inc in United States of America. The device registration started on July 14, 2016.

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.