Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd - Celsius Flutter Bi-Directional 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. Celsius Flutter Bi-Directional Catheter - Catheter, cardiac, electrophysiological mapping
Single Device Product
44867 Catheter, cardiac, electrophysiological mapping
This is a steerable, multi-electrode catheter with a deflectable tip, and a usable length of 115 cm. The
deflectable tip has one 8 mm platinum/iridium tip electrode and three platinum/iridium ring electrodes used
for pacing and recording ECG signals. The catheters are used in conjunction with a Radiofrequency (RF)
Generator, compatible interface cables, and a grounding (dispersive) pad.
Indicated for cardiac electrophysiological mapping (stimulation and recording) and, when used in
conjunction with a radiofrequency generator, for cardiac ablation.
Nil variant (as 1 device) Nil
No Specific Conditions included on Record
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