אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 62752 - pleural drainage valve - the cook chest drain valve is intended for use with a pleural drainage catheter to help remove air from the pleural cavity.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 17115 - battery charger - the charger is to be used with the cook doppler blood flow monitor as a means to supply an electrical charge to rechargeable batteries within the monitor.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 35419 - tube, feeding, gastrostomy - used in conjunction with cook endoscopy peg/flow systems for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional support.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 43978 - embolization implant inserter - the detachable pda coil delivery system is used for coil embolistaion procedures to position and deliver coils thorough a catheter. the detachable pda coil delivery system allows the operator to reposition, retrieve or exchange coils prior to their release by mechanically controlling the attachment and detachment of the coil to the positioning device. this device is intended for patent ductus arteriosus (pda) closure. the detachable coil delivery system provides safe delivery of embolization coils when correct positioning is especially critical.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the zenith low profile aaa endovascular graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms, having the morphology suitable for endovascular repair.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 35094 - catheter guide wire - the straight and curved wire guides are tfe-coated stainless steel with a 3cm, 4cm or 7cm flexible tip (depending on the length of the wire guide). the double curved wire guide also consists of tfe-coated stainless steel and has a 4cm flexible tip. the wire have an inner gold coil for enhanced visibility. the pre-curved distal tip mimics anatomy and is very flexible. this allows for atraumatic vessel engagement during wire guide manipulation. the lunderquist extra stiff wire guides are intended to facilitate catheterization and/or placement of devices during vascular diagnostic procedures and vascular interventional procedures. the lunderquist extra stiff wire guides are intended for use in the major vessels, the aorta and vena cava including their access vessels and adjacent vessels.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 46455 - torque manipulating device - intended to aid in the manipulation and control of guide wires.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 47685 - aortic stent - the zenith dissection endovascular stent is a one-piece cylindrical device constructed from self-expanding nitinol stent segments sewn together with polyester suture. the stents are uncovered to avoid blockage of dominant spinal cord intercostal arteries and allow for deployment of the stents across branch vessel origins as needed to treat the dissection. the zenith dissection endovascular stent with the z-trak plus introduction system is indicated for the endovascular treatment of patients with symptomatic aortic dissection distal to the left subclavian artery (can be used to provide support to delaminated segments of the aorta typical in dissection) having morphology suitable for endovascular repair, including: a) adequate iliac/femoral access compatible with the required introduction systems; when used together with the zenith tx2 dissection endovascular graft with pro-form. b) radius of curvature greater than 35mm along the entire length of aorta intended to be treated, by the zenith dissection endovascular stent. c) localised angulation less than 45 degrees and d) diameter at intended implant site (measured outer wall to outer wall) of no greater than 38mm (true lumen) and no less than 20mm (total aortic diameter).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - a two-piece cylindrical endovascular graft consisting of proximal & distal components, constructed of woven polyester sewn to self-expanding z-stents. fully stented to provide stability and the expansile force to open the lumen of the graft during deployment. z-stents also provide attachment/seal of the graft to the vessel wall. barbs used for added fixation. radiopaque gold markers facilitate fluoroscopic visualisation. shipped preloaded onto either a 20fr or 22fr z-trak plus intro. system. intended for treatment of patients with atherosclerotic aneurysms, symptomatic acute or chronic dissections, contained ruptures, growing aneurysms and/or resulting in distal ischaemia, in the descending thoracic aorta having vascular morphology suitable for endovascular repair.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - distal extensions used to provide additional length to the endovascular graft distally or to increase the length of overlap between components. it is deployed from an introduction system and a single locking mechanism secures the graft to the introduction until it is released. to facilitate visualisation, gold radiopaque markers are positioned on the ends of the graft. gold markers are placed on stent apices at the proximal and distal graft margins to assist with deployment accuracy. the distal extension is a component of the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair including: ? iliac/femoral anatomy that is suitable for access with the required introduction systems, ? nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic aneurysm or ulcer o with a length of at least 20mm, and o with a diameter measured outer-wall-to-outer-wall of no greater than 42mm and no less than 20mm