Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 17846 - catheter, intravascular, guiding - designed to provide accessibility and maneuverability in the cardiac anatomy. it is equipped with an integrated steering mechanism allowing for bi-directional deflection. it has 4 electrodes on the outer sheath to interface with compatible navigation systems to allow the visualization of the sheath. the vizigo 8.5f steerable sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. the sheath curve can be visualized when used with compatible carto ep navigation systems.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 61785 - cardiac radio-frequency ablation system catheter - the catheter shaft measures 7.5f with 8f ring electrodes. for ablation, the catheter is used in conjunction with a compatible radiofrequency (rf) generator and a dispersive pad. all of the electrodes can be used for stimulation purposes but the tip electrode serves to deliver rf energy from the generator to the desired ablation site. indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a compatible radiofrequency generator, for cardiac ablation. the qdot micro bi-directional catheter provides a real-time measurement of temperature and contact force between the catheter tip and heart wall, as well as location information when used with the carto system.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 61785 - cardiac radio-frequency ablation system catheter - the catheter shaft measures 7.5f with 8f ring electrodes. for ablation, the catheter is used in conjunction with a compatible radiofrequency (rf) generator and a dispersive pad. all of the electrodes can be used for stimulation purposes but the tip electrode serves to deliver rf energy from the generator to the desired ablation site. indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a compatible radiofrequency generator, for cardiac ablation. the qdot micro uni-directional catheter provides a real-time measurement of temperature and contact force between the catheter tip and heart wall, as well as location information when used with the carto system.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 63646 - surgical irrigation pump - for the delivery of irrigation solutions when used in conjunction with a compatible irrigation tubing set, either independently or with a compatible radiofrequency (rf) generator

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 60784 - cardiac radio-frequency ablation system - to generate radiofrequency energy for delivery to to specific sites in the heart via compatible therapeutic ablation catheters

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 46355 - electrophysiology cardiac catheter, single-use - designed to facilitate electrophysiological mapping of the heart with the carto 3 ep navigation system. the deployment in the heart chamber is through an 8.5f guiding sheath. the catheter is deflectable in both a d and f curve configuration and consists of multiple 2f spines on its distal tip, each spine having multiple platinum electrodes that are used for recording and stimulation. the catheter also has a central electrode that can be used as an internal close unipolar reference electrode the octaray mapping catheter with trueref? technology is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart i.e. recording or stimulation only. this catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. the catheter provides location information only when used with compatible versions of carto 3 ep navigation system.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 46355 - electrophysiology cardiac catheter, single-use - percutaneous transvascular access through a compatible catheter or a compatible intravascular sheath to target intracardiac structures. the catheter consists of a circular spine on its distal tip, with platinum electrodes that can be used for stimulation and recording in the atrial region of the heart. indicated for multiple electrode electrophysiological recording and stimulation of the atrial region of the heart. when used in conjunction with a radiofrequency (rf) ablation catheter and a compatible multi-channel generator, the catheter can be used to facilitate ablation of cardiac arrhythmias.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 47487 - medical device electrical cable, general purpose - cables used with compatible therapeutic catheters, radiofrequency (rf) generator and the carto 3 system for catheter-based cardiac electrophysiological mapping and ablation

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 65067 - cardiac irreversible electroporation system generator - the generator is intended for cardiac electrophysiology procedures. it delivers pulsed field (pf) ablation during cardiac ablation procedures.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - 46355 - electrophysiology cardiac catheter, single-use - catheter enables electrophysiological mapping of heart with carto3 system. access via 8.5f guiding sheath. bidirectional deflectable catheter:6 parallel spines joined form 3 loops on deflectable tip. each spine has active electrodes that form grid, for stimulating & recording. 8 platinum electrode/spine equals 6x8 electrode grid; 6 platinum electrode/spine equals 6x6 electrode grid. sensor in deflectable tip transmits location info & electrodes below the spine allow tip visualization on carto the optrell? mapping catheter with trueref? technology is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. this catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.