Summary for ARTG Entry:
Terumo Australia Pty Ltd - Radio-frequency ablation system renal denervation catheter
ARTG entry for
Medical Device Included Class IIb
Terumo Australia Pty Ltd
PO Box 312,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class IIb
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Shanghai AngioCare Medical Technology Ltd
590 Ruiqing Road Building 6 Suite 301
East Zhangjiang High-Tech Park, Shanghai,
1. Radio-frequency ablation system renal denervation catheter
Single Device Product
58893 Radio-frequency ablation system renal denervation catheter
The Iberis renal artery radio-frequency ablation catheter is designed to deliver low-level radio-frequency
energy through the wall of the renal artery to achieve renal denervation
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:55:34 AEDT
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