Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd - Decanav Electrophysiology Catheter - Catheter, cardiac,
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd
PO Box 134,NORTH RYDE BC, NSW, 1670
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.
Biosense Webster Inc
33 Technology Drive
Irvine, California, 92618
United States Of America
1. Decanav Electrophysiology Catheter - Catheter, cardiac, electrophysiological mapping
Single Device Product
44867 Catheter, cardiac, electrophysiological mapping
Used with a cardiac mapping system to reference multiple catheters tip locations in the heart. Has a high
torque shaft with a deflectable tip section containing an array of electrodes that can be used for stimulation
and recording of cardiac electrical signals. Has a single proximal electrode that can be used for unipolar
recording signals. The tip deflection is controlled by a proximal hand piece that features a thumb operated
The Decanav catheter is indicated for electrophysiological mapping of cardiac structure i.e., recording and
stimulation, including in the Coronary Sinus. In addition the Decanav catheter is used with compatible
CARTO 3 EP Navigation systems to provide catheter tip location information.
Shape (of tip) F - Curve
Shape (of tip) D - Curve
No Specific Conditions included on Record
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