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

culpan medical pty ltd - 43978 - embolization implant inserter - the detachment control device is a hand-held, battery powered device designed specifically to power the delivery of the web aneurysm embolization system.

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

culpan medical pty ltd - 32151 - peripheral/coronary vasculature catheter, infusion - a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. the physician inserts the catheter into the vein or artery through the skin using a sheath or guidewire. the device can then be navigated to the treatment site. the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site. the via catheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. contraindications; the via is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & dmso (dimethyl sulfoxide).

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

culpan medical pty ltd - 35449 - prosthesis, internal, embolization, intravascular - the web embolisation device lines the inner surface and spans the neck in the treatment of cerebrovascular aneurysm or lesion. during treatment, the physician selects the appropriate device size based on the size, shape and location of the intracranial aneurysm or other vascular abnormality to be occluded. the device is delivered to the treatment site on a delivery device through standard neuro-interventional wire-reinforced microcatheters. the web aneurysm embolisation system is intended for the endovascular embolisation of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae (avf). the web aneurysm embolisation system is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolisations in the peripheral vasculature.

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

culpan medical pty ltd - 44864 - vena cava filter, optional - the filter is self centreing and has memory shaped nitinol struts designed for clot capture. retention anchors (hooks) are located in caudal portion for fixation to vessel wall. it is flexible and expands to internal diameter of ivc and imparts outward radial force for positioning and stability. the 100cm filter system is suitable for antecubital and popliteal delivery. the option? elite vena cava filter 100cm system is intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the following conditions: - pulmonary thromboembolism when anticoagulant therapy is contraindicated, - failure of anticoagulant therapy in thromboembolic diseases, - emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced, - chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated. the filter may be removed according to supplied instructions in patients who no longer require a filter. retrieval of the filter can only be performed by the jugular approach. the angiographic vessel dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

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

culpan medical pty ltd - 56630 - universal tube holder - sterile device to secure tubing to a patient.

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

culpan medical pty ltd - 44864 - vena cava filter, optional - the filter is self centreing and has memory shaped nitinol struts designed for clot capture. retention anchors (hooks) are located in caudal portion for fixation to vessel wall. it is flexible and expands to internal diameter of ivc and imparts outward radial force for positioning and stability. the 70cm filter system is suitable for jugular or femoral delivery. indicated for the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) in the following conditions: - pulmonary thromboembolism when anticoagulants are contraindicated - failure of anticoagulant therapy in thromboembolic disease - emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced - chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated the filter may be removed according to supplied instructions in patients who no longer require a filter. retrieval of the filter can only be performed by the jugular approach. the angiographic vessel dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

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

culpan medical pty ltd - 58172 - thrombectomy rotational catheter - intended to be used for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts and for the controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature.

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

culpan medical pty ltd - 17927 - catheter, snare - device consists of a snare device with three nitinol and platinum preformed loops which slide relative to one another. the loops are introduced into the delivery catheter which has a radiopaque marker band at the distal tip. the kit includes a torque handle and an introducer. the product comes packaged in a protective hoop holder. the atrieve? vascular snare is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.

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

culpan medical pty ltd - 47611 - liver biopsy procedure kit - for transjugular liver access biopsy.

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

culpan medical pty ltd - 35824 - drainage kit, wound - a packaged collection of items, including catheter and accessories, to remove fluid or purulent material from a wound, infected area or other part of body.