Summary for ARTG Entry:
Biotronik Australia Pty Ltd - AlCath Flutter Flux Black G eXtra - Catheter, cardiac, ablation
ARTG entry for
Medical Device Included Class III
Biotronik Australia Pty Ltd
Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073
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.
, Binzen, D-79589
1. AlCath Flutter Flux Black G eXtra - Catheter, cardiac, ablation
Single Device Product
35855 Catheter, cardiac, ablation
Temporary unidirectional steerable quadripolar irrigated catheters for sensing of intracardiac signals and
RF ablation of cardiac tachyarrhythmia. A thermocouple monitors/controls temperature during RF current
ablation. Gold electrodes minimise transition resistances, maximising conductance. A deflectable tip has
increased lateral stability, is softer & more flexible than in the transverse direction. Ablations in the
cavo-tricuspid isthmus in the right atrium & treating atrial flutter.
The catheters of the AlCath® family are temporary unidirectional steerable quadripolar catheters for
intracardiac RF ablation as well as for sensing of intracardiac signals. They are intended for treatment of
supraventricular/ventricular cardiac tachyarrhythmia or AV node reentry tachycardia.
Nil variant (as 1 device) NIL
No Specific Conditions included on Record
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