ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

teleflex medical australia pty ltd -

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 17927 - catheter, snare - intended to be used for interventional removal of foreign bodies, from vessels that do not have an "open catching end". generally, for the removal of foreign bodies or manipulation of catheters, wires, etc. from the vascular vessel system. support by the arrangement of loops with crossover technologies. not for use in the central circulatory system.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 47932 - multiple peripheral arteries stent - a balloon-expandable cocr stent, covered with eptfe graft material, pre-mounted on the balloon of an over the wire (otw) delivery system. available in 3 stent designs. ?12 & 14mm can be maximally post-dilated with an appropriate balloon to 20mm, ?16 & 18mm can be post-dilated to 24mm & ?20 ? 24mm can be post-dilated to 30mm. compatible with 0.035? (0.89mm) guide wires. two radiopaque markers located underneath the balloon fluoroscopically identify the position of the stent on the balloon. the ?begraft aortic stent graft system? is indicated for; ? the implantation in the native and/or recurrent coarctation of the aorta (coa) on adolescent or adult patients with the following clinical conditions: -- stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or noninvasive imaging, i.e. echocardiography, magnetic resonance imaging (mri), ct scan; -- stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function; -- stenosis of the aorta where balloon angioplasty is ineffective or contraindicated; -- stenosis diameter <20% of the adjacent vessel diameter. stenosis that would present increased risk of vascular damage of disruption. ? and furthermore for restoring and improving the patency of the iliac arteries.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 43521 - bare-metal aortic stent - the sinus-xl 6f stent is self-expanding and made of nitinol, a nickel titanium alloy, with tantalum markers (4 distal and 3 proximal markers). the stent does not show any filament welding points or joints; it is mr-capable with static magnetic fields of 3.0 tesla or less. the stent can be repositioned. the system comprises two components: 1. sinus-xl 6f stent (self-expanding nitinol stent in closed-cell design) and 2. 6 french application set, 100 cm long (coaxial pull-back system) indicated for implantation in the abdominal aorta and the straight section of the descending thoracic aorta: - vascular occlusions / stenosis - dissection - insufficient outcome of angioplasty treatment - residual stenoses following balloon angioplasty - elastic stenoses of bypass anastomoses - endoleak type 1a and 1b in the vena cava: - superior and inferior vena cava syndrome - obstructions of the vena cava caused by malignant and benign tumors

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 43521 - bare-metal aortic stent - the sinus-xl flex is self-expanding stent and made of nitinol a nickel titanium alloy, with tantalum markers. the stent does not show any filament welding points or joints. the system comprises two components: 1. sinus-xl flex (self-expanding nitinol stent in open-cell design) and 2. 10 french application set, 100 cm long (coaxial pull back system). indicated for implantation in the abdominal aorta and the descending aorta for: - aortic coarctations - vascular occlusions / stenoses - insufficient outcome of angioplasty treatment - dissection - residual stenoses following balloon angioplasty - elastic stenoses of bypass anastomoses - endoleak type 1a and 1b indicated for implantation in the vena cava for: - superior and inferior vena cava syndrome - obstructions of the vena cava caused by malignant and benign tumors indicated for implantation in the iliofemoral veins for: - symptomatic obstructions

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 47932 - multiple peripheral arteries stent - the system consists of; a balloon-expandable cobalt-chromium (l605) stent, covered with an eptfe graft material, which is pre-mounted on the balloon of an over the wire (otw) stent delivery system. the delivery system is compatible with 0.035? (0.89mm) guide wires and is available in usable lengths of 75cm and 120cm. two radiopaque markers located underneath the balloon identify the begraft peripheral stent position and fluoroscopically mark the working length of the balloon. the begraft peripheral stent graft system is indicated for intraluminal chronic placement in iliac and renal arteries for: ? restoring and improving the patency and ? treating aneurysms, acute perforations, acute ruptures and fistulas.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 57788 - mesh-sleeve coronary artery stent - the begraft coronary stent graft system consists of: - a balloon-expandable cobalt-chromium (l605) stent, covered with an eptfe graft material, which is - pre-mounted on the balloon of a rapid exchange (rx)stent delivery system. the delivery system is compatible with 0.014? guide wires and is available in usable lengths of 143 cm and 153 cm. the begraft coronary stent graft system is indicated for transluminal implantation in coronary arteries or aorto-coronary bypass grafts for the treatment of: 1. acute perforation or rupture of coronary arteries. 2. aneurysm of coronary arteries or coronary bypass-vein graft.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

teleflex medical australia pty ltd - 10688 - catheter, angiography - consists of inner, braided high pressure lumen, used for pressure measurement & rapid delivery of contrast medium, & an outer lumen that ends 3-15cm proximal to the distal end with side-holes for pressure measurement only. the inner & outer lumens are joined using an adapter junction at the proximal end. the adapter junction has a side port fitted with an extension tubing & stopcock assembly for fluid flow & pressure measurement in the outer lumen. a straightener is supplied with pigtail models. the langston dual lumen catheter is intended for use as an angiographic pressure measurement catheter and for high pressure contrast injections. each langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. this type of pressure measurement is useful in determining trans-valvular, intravascular and intra-ventricular pressure gradients.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

teleflex medical australia pty ltd - 36079 - catheter introducer, haemostasis valve - intended to maintain haemostasis during the use of diagnostic or interventional devices. indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8f (0.105" or 2.67mm) during diagnostic/interventional procedures. may include a torque device as an aid for steering a separate supplied guidewire within the vascular anatomy and sidearm extension tubing.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

teleflex medical australia pty ltd -