Summary for ARTG Entry:
Pacing Importers Pty Ltd - COBRA Fusion Ablation System - Electrosurgical system, general-purpose
ARTG entry for
Medical Device Included Class III
Pacing Importers Pty Ltd
8-12 Alma Road,ST KILDA, VIC, 3182
ARTG Start Date
Medical Device Class III
- 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.
Endoscopic Technologies Inc dba Estech
Suite 100 / 2603 Camino Ramon
San Ramon, CA, 94583
United States Of America
1. COBRA Fusion Ablation System - Electrosurgical system, general-purpose
Medical device system
44776 Electrosurgical system, general-purpose
The system comprises a flexible ablation catheter, designed to conform to specific anatomy of tissue to be
ablated with integrated suction stabilizer to engage tissue under vacuum for constant catheter
electrode/tissue contact. Magnetically coupled, the introducer is used to advance the catheter to desired
anatomical position. The catheter allows any combination of electrodes to be activated. Connected to the
ESU, RF energy is directed from active electrodes in selected Bipolar/Monopolar mode.
The ESTECH Cobra Fusion Ablation System is intended to ablate cardiac tissue during cardiac surgery
using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU)
Length (mm) 50 and 150
No Specific Conditions included on Record
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Produced at 10.11.2017 at 08:33:56 AEDT
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