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

culpan medical pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the sofia? catheter is used to remove emboli and thrombi from selected blood vessels having longer working lengths (>115cm). it is non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. the distal segment is steam-shapeable to facilitate vessel selection and also has a hydrophilic coating for navigation through the vasculature. the radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. 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

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

culpan medical pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the sofia? catheter is used to remove emboli and thrombi from selected blood vessels and to support and facilitate the use of additional neuro devices. 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 and usually positioned in distal anatomy. it has a hydrophilic coating for navigation and the radiopaque marker is located at the distal end of the catheter for visualization. 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.

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

culpan medical pty ltd - 45851 - stent, vascular, carotid artery - a self expanding, dual-layer braided closed cell design stent with a 5 french rapid exchange (rx) delivery catheter. the stent is designed to expand to a pre-determined diameter when deployed by the delivery catheter. the implant is produced with various unconstrained outer diameters ranging from 5-8 mm and dual layer lengths of 20-40 mm. upon exiting the delivery catheter at the target lesion, the implant expands to the vessel lumen diameter. the casper carotid stent system is indicated for use in patients with carotid arterial atherosclerotic disease.

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 -

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

culpan medical pty ltd -

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

culpan medical pty ltd - 46352 - stent, vascular, intracranial - a self-expanding nickel titanium, single wire braid, compliant closed cell paired-stent design that can be simultaneously deployed and retrieved by a single operator. the fred system features integrated dual layer coverage designed to focus mainly at the neck of an aneurysm. the fred system has distal and proximal markers on its ends as well as interweaved helical marker strands delineating the inner working length of the stent to provide fluoroscopic visibility. the fred system is intended for endovascular embolization of intracranial neurovascular aneurysms. the fred system may also be used with embolic coils for the treatment of intracranial neurovascular lesions.

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

culpan medical pty ltd - 17846 - catheter, intravascular, guiding - a single lumen catheter to be introduced over a steerable guidewire to access small, tortuous vasculature. semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. dual radiopaque markers at the distal end facilitate fluoroscopic visualization. the outer surface is coated with a hydrophilic coating to reduce friction during navigation and a luer fitting on the microcatheter hub is used for theis used for the attachment of accessories. the headway duo microcatheter is intended for general intravascular use, including the peripheral and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials. the headway duo microcatheter is intended for neurovascular use, for the infusion of diagnostic agents, such as contrast media, and therapeutic agents that have been cleared or approved for use in the neurovasculature and are compatible with the inner diameter of the headway duo microcatheter.

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

culpan medical pty ltd - 42988 - low-pressure tubing connector - intended to be used to connect various devices for the administration of solutions.