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

penumbra neuro australia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the aspiration catheter is inserted through a guide catheter or long femoral sheath. once in place, the aspiration catheter provides a conduit to remove thrombus using the size-matched separator. the aspiration tubing connects the aspiration catheters to the penumbra aspiration pump. the indigo system aspiration catheter d ? kit includes an aspiration catheter d, optional catheter accessories (rotating hemostasis valve (rhv) and introducer), and aspiration tubing. the indigo aspiration system is designed to remove thrombus from the vasculature using mechanical thrombectomy.

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

penumbra neuro australia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the 3d revascularization device is deployed within the thrombus and then retrieved into the reperfusion catheter. the 3d revascularization device has an open-body, three-dimensional lattice design and is delivered to the site of occlusion via a compatible inner microcatheter (e.g. with an id of 0.025 in [0.635 mm]) through the reperfusion catheter. as part of the penumbra system, the penumbra 3d revascularization device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral ? m1 and m2 segments) within 8 hours of symptom onset. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.

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

penumbra neuro australia pty ltd - 41978 - surgical irrigation/aspiration system - the pump max canister is a 1000ml canister. the canister is a non-sterile, single-use accessory component of the penumbra pump max and is used to collect aspirated fluid/thrombus. the canister comes pre-assembled with a removable lid, pump canister tubing, and filter, and is supplied for use with the penumbra pump max.

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

penumbra neuro australia pty ltd - 17846 - catheter, intravascular, guiding - device name: benchmark bmx96 system product codes: bmx96100sim125, bmx96100msim125, bmx96100h1125, bmx96100mh1125, bmx96100ber125, bmx96100mber125, bmx96100simv125, bmx96100msimv125, bmx96100, bmx9690sim125, bmx9690msim125, bmx9690ber125, bmx9690mber125, bmx9690simv125, bmx9690msimv125, bmx9690, bmx9680ber105, bmx9680 brief description:the benchmark bmx96 system is comprised of the benchmark bmx96 delivery catheter, neuron 6f select catheter, and a dilator. the benchmark bmx96 delivery catheter can be used individually with a 0.038 in. [0.97 mm] guidewire or together with the neuron 6f select catheter to access the desired anatomy. indication: the benchmark bmx96 system is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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

penumbra neuro australia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the aspiration catheter is inserted through a guide catheter or long femoral sheath. once in place, the aspiration catheter provides a conduit to remove thrombus using the size-matched separator. the aspiration tubing connects the aspiration catheters to the penumbra aspiration pump. the indigo system aspiration catheter kit includes an aspiration catheter, optional catheter accessories (rotating hemostasis valve (rhv) and introducer), and aspiration tubing. the indigo aspiration system is designed to remove thrombus from the vasculature using mechanical thrombectomy.

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

penumbra neuro australia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the aspiration catheter is inserted through a guide catheter or long femoral sheath. once in place, the aspiration catheter provides a conduit to remove the thrombus using the size-matched separator. as part of the indigo? aspiration system, the indigo sterile aspiration tubing is indicated to connect the indigo aspiration catheters to the penumbra aspiration pump. as part of the indigo aspiration system, the indigo cat rx aspiration catheters are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. the indigo sterile aspiration tubing is indicated to connect the indigo cat rx aspiration catheters to the penumbra aspiration pump.

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

penumbra neuro australia pty ltd - 17846 - catheter, intravascular, guiding - the benchmark bmx81 access system is intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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

penumbra neuro australia pty ltd - 41978 - surgical irrigation/aspiration system - indigo aspiration tubing : as part of the indigo aspiration system, the indigo sterile aspiration tubing is indicated to connect the indigo aspiration catheters to the penumbra pump max.

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

penumbra neuro australia pty ltd - 60940 - neurovascular embolization coil - the pod system functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of bare-platinum coils to achieve occlusion in an equivalent fashion to existing bare-platinum embolization coils, including the penumbra coil system. the pod system consists of three components: a coil implant, attached to a detachment pusher, and a detachment handle. for pod coils with nominal sizes ? 6mm: pod system is indicated for the embolization of: ? intracranial aneurysms. ? other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. ? arterial and venous embolizations in the peripheral vasculature. for pod coils with nominal sizes > 6mm: pod system is indicated for the arterial and venous embolizations in the peripheral vasculature.

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

penumbra neuro australia pty ltd - 43980 - embolization implant kit - the smart coil detachment handle is a plastic handle used to mechanically detach the penumbra smart coil implant. the detachment handle is a sterile single patient device.