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Thrombectomy rotational catheter

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.

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Class IIb
Class IIb
Thrombectomy rotational catheter
Australia TGA ARTG Registered Device
Good Name: Culpan Medical Pty Ltd - Thrombectomy rotational catheter
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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.

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
Manufacturer
Country
United States of America
Address
1445 Flat Creek Road, Athens, Texas, 75751