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 - 60940 - neurovascular embolization coil - the web aneurysm embolization system consists of an implantable embolization device attached to a delivery device. the device is manufactured from nitinol wires in a braided, self-expanding mesh configuration available in a broad range of diameters and lengths to meet the specific needs of the patient. the device is separated from the delivery device by the use of a separate battery-powered detachment control device. the device is supplied sterile and is single use. the web aneurysm embolization system is intended for the endovascular embolization of ruptured and unruptured intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae(avf). the web aneurysm embolization 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.the device should only be used by physicians who have undergone appropriate training.

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. via 21, 27, 33 - the via microcatheter is intended for the introduction of non-liquid interventional devices (such as aneurysm embolization devices (e.g. web device) / stents / flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature. via 17 - the via microcatheter is intended for the introduction of non-liquid interventional devices (such as aneurysm embolization devices (e.g web device, coils) / stents / flow diverters) and infusion of diagnostic (such as contrast media) or nonliquid therapeutic agents into the neuro, peripheral, and coronary vasculature.

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

culpan medical pty ltd - 60939 - neurovascular embolization plug - the phil device embolizes and/or occludes the blood flow in vascular malformations. a microcatheter attached to the pre-filled phil syringe is advanced to the target lesion and the phil is delivered in liquid phase under fluoroscopic control. upon contact with blood, the liquid embolic precipitates/solidifies in-situ within 3 minutes resulting in a polymeric embolus localized in the vasculature. the phil is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors.

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

culpan medical pty ltd -