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

microport crm pty ltd - 61785 - cardiac radio-frequency ablation system catheter - the device is a flexible, insulative, luminal catheter with a deflectable tip comprised of thermoplastic elastomer and several platinum electrodes. in the tip a thermocouple temperature sensor is embedded. the high torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. all of the electrodes may be used for cardiac mapping and stimulation purposes; besides, the tip electrode may also be used for ablation. the firemagic cardiac rf ablation catheter is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording), and when used with radiofrequency generator, for the treatment of a trioventricular nodal reentrant tachycardia and a trioventricular reentrant tachycardia via catheter based radiofrequency ablation

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

microport crm pty ltd - 61785 - cardiac radio-frequency ablation system catheter - the device is a flexible, insulative, luminal catheter with a deflectable tip comprised of thermoplastic elastomer and several platinum electrodes. in the tip a thermocouple temperature sensor is embedded. the high torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. all of the electrodes may be used for cardiac mapping and stimulation purposes; besides, the tip electrode may also be used for ablation. the firemagic cardiac rf ablation catheter is indicated for catheter based cardiac electrophysiological mapping (stimulating and recording), and when used with radiofrequency generator, for the treatment of a trioventricular nodal reentrant tachycardia and a trioventricular reentrant tachycardia via catheter based radiofrequency ablation

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

microport crm pty ltd - 61785 - cardiac radio-frequency ablation system catheter - the firemagic 3d irrigated ablation catheter has a high-torque shaft with a deflectable tip section containing an array of platinum electrodes. all electrodes can be used for the purposes of cardiac electrophysiological mapping and stimulation, and the tip electrode can also be used for ablation. tip deflection is controlled at the proximal end by a handle. it has an irrigated lumen and is integrated with a 3d location sensor the firemagic 3d irrigated ablation catheter is indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) in conjunction with a 3d ep navigation system, and when used with the rf generator, for the treatment of atrial fibrillation (af) via catheter-based radiofrequency ablation in patients of 18 or older age. indications include drug refractory symptomatic paroxysmal atrial fibrillation and persistent atrial fibrillation.

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

microport crm pty ltd - 46355 - electrophysiology cardiac catheter, single-use - the easyloop circular mapping catheter is composed of a circular loop, a deflectable section, the main body and a control handle. ten electrodes equally spaced on the distal tip of circular loop which is of a fixed diameter. all electrodes can be used for the purposes of cardiac electrophysiological mapping and stimulation. the deflectable section is controlled by the thumbknob on the handle. at the end of the handle, a connector for a connecting cable is provided. the easyloop catheter is indicated for electrophysiological mapping the cardiac structures of the heart, for recording or stimulation. the catheter is designed to obtain electrograms in the atrial region of the heart. indications include paroxysmal atrial fibrillation and persistent atrial fibrillation.

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

microport crm pty ltd - 46355 - electrophysiology cardiac catheter, single-use - easyfinder steerable curve diagnostic catheter has a high-torque shaft with a steerable curve section containing an array of platinum electrodes. the electrode tip can be deflectable. the high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. the easyfinder steerable curve diagnostic catheter is indicated for use in electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.

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

microport crm pty ltd - 46355 - electrophysiology cardiac catheter, single-use - easyfinder fixed curve diagnostic catheter has a high-torque shaft with a fixed curve section containing an array of platinum electrodes. the tip of the electrode has a preformed curve. the high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. the easyfinder fixed curve diagnostic catheter is indicated for use in electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.

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

microport crm pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - the device is a non-compliant percutaneous transluminal coronary angioplasty (ptca) rapid exchange system that consists of an integrated shaft and a balloon at the distal end of the catheter. the proximal end of the catheter has a standard luer to inflate or deflate the balloon by contrast medium. the coaxial dual lumen distal shaft creates the rapid exchange capability. the balloon catheter is coated with hydrophilic coating. the firefighter nc ptca balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and for balloon dilatation of a stent after implantation.

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

microport crm pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - the device is a semi-compliant percutaneous transluminal coronary angioplasty (ptca) rapid exchange system that consists of an integrated shaft and a balloon at the distal end of the catheter. the proximal end of the catheter has a standard luer to inflate or deflate the balloon by contrast medium. the coaxial dual lumen distal shaft creates the rapid exchange capability. the balloon catheter is coated with hydrophilic coating. firefighter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

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

microport crm pty ltd - 46265 - cardiac mapping system - the intended use of the columbus 3d is catheter-based cardiac electrophysiological (ep) procedures. the device can assist the doctor to diagnose during the electrophysiological operation. and the columbus 3d provides information about the electrical activity of the heart and about catheter location during the procedure. the system can be used on patients who are eligible for a conventional electrophysiological procedure.

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

microport crm pty ltd - 13215 - infusion pump, general-purpose - optimablate? irrigation pump is a peristaltic pump designed to work in conjunction with the optimablate rf generator to deliver irrigation solution at specified flow rates to irrigated catheters for cooling purposes.