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

culpan medical pty ltd -

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

culpan medical pty ltd - 47135 - intravascular catheter guidewire extension - the traxcess docking wire is an accessory used to extend the overall length of the traxcess guidewire for facilitating catheter placement. to extend the guidewire length, the proximal end of the traxcess guidewire is connected to the traxcess docking wire. the traxcess docking wire is removed when it is not needed.

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

culpan medical pty ltd - 46352 - stent, vascular, intracranial - the device is a self-expanding nickel titanium, single wire braid, compliant, closed-cell design that can be deployed and retrieved by a single operator. the device is packaged sterile as a single unit with an introducer sheath and a detachable push wire. the device is an intraluminal support device (stent) intended for use with embolic coils for the treatment of intracranial neurovascular diseases. the device is also intended to be used in the peripheral vasculature.

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

culpan medical pty ltd -

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

culpan medical pty ltd - 60940 - neurovascular embolization coil - microplex coil system (mcs) consists of an implantable coil attached to a delivery system, v- trak delivery pusher. the mcs complex coils establish the initial framework in the treatment of the cerebrovascular aneurysm or lesion. once initial framework is established by one or more complex framing coils, additional mcs complex and helical coils provide filling of the aneurysm or lesion. endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as av fistulae; for the vascular occlusion of of blood vessels within the neurovascular system; for arterial and venous embolizations in the peripheral vasculature

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

culpan medical pty ltd -

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

culpan medical pty ltd -

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

culpan medical pty ltd - 32584 - catheter, intravascular, occluding - the device is a coaxial balloon catheter with an inner lumen for a guidewire and an outer lumen for inflation and deflation of the balloon. the balloon catheter is compatible with 0.36 mm or smaller guidewires and can be inflated and deflated independently of guidewire position. the balloon catheter is available in different sizes and incorporates radiopaque markers to facilitate fluoroscopic visualization and a distal purge hole to purge air from the catheter prior to use. for single use only. the scepter occlusion balloon catheter is intended for use in the peripheral and neuro vasculature where temporary occlusion is desired. the balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. the balloon catheter also offers balloon assisted embolization of intracranial aneurysms. intended for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials. it is

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

culpan medical pty ltd - 35094 - catheter guide wire - the traxcess consists of a proximal 0.014 inch diameter stainless steel shaft and a distal tapered nitinol wire contained within 0.012 inch or 0.007 inch platinum and stainless steel coils. it is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. the distal tip of the guidewire is able to be shaped by the clinician to allow easier access. intended for the general intravascular use, including neuro and peripheral vasculature. this wire can be steered to faciltate the selective placement of diagnostic or therapeutic catheters. this device is not intended for use in the coronary arteries.

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

culpan medical pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the sofia? catheter is used to support and facilitate the use of additional neuro devices and to remove emboli and thrombi from selected blood vessels. it is a non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. the distal segment is steam-shapeable to facilitate vessel selection. it is usually positioned in more proximal anatomy. it has a hydrophilic coating for navigation and the radiopaque marker is located at the distal end for visualisation. the sofia? catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. the sofia? catheter can be used to facilitate introduction of diagnostic or therapeutic agents. the sofia? catheter is not intended for use in coronary arteries. moreover, the sofia? catheter is intended for use in removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the peripheral and neuro vasculatures.