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The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries.

The subject Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.

072 Aspiration Catheter: As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump 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, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment. Aspiration Tubing: As part of the 072 Aspiration System, the Aspiration Tubing is intended to connect the 072 Aspiration Catheter to a compatible suction pump.

The 072 Aspiration Catheter is a single lumen, variable stiffness catheter. The catheter has a hydrophilic coating to reduce friction during use. The catheter includes radiopaque markers on the distal end for angiographic visualization and a Luer hub on the proximal end allowing attachments for flushing and aspiration. The Delivery Tool is an optional accessory for use with the 072 Aspiration Catheter and should be removed prior to aspiration. The 072 Aspiration Catheter, Delivery Tool. Rotating Hemostasis Valve, and Flow Switch are included in the package. The Aspiration Tubing is provided in a separate package. For the aspiration source, the 072 Aspiration Catheter is used in conjunction with a compatible suction pump with prespecified performance parameters that is connected using the Aspiration Tubing.

The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The subject SelectFlex Neurovascular Access System Family is a line extension to expand the previously cleared device (K211893) by offering a new SelectFlex III 064 Neurovascular Access Catheter with a diameter of 6F, a 6F dilator, an introducer sheath, and a 4.5F Access Tool that can be used with the catheter to access the desired anatomy. The 4.5F Access Tool is an accessory provided with the SelectFlex III 064 Neurovascular Access Catheter and is packaged in the same sterile pouch with the SelectFlex III 064 Neurovascular Access Catheter and accessories as part of the SelectFlex Neurovascular Access System Family.

The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The SelectFlex Neurovascular Access System Family consists of sterile, single-use intravascular catheters used to facilitate access to target vasculature during interventional procedures. The system is composed of a SelectFlex Neurovascular Access Catheter, a 3cc Mode Control Syringe, a 7Fr Peel Away Introducer, Luer Activated Valve and a Dilator (only for versions with a Long Hydrophilic coating to ease dermal entry). The SelectFlex Neurovascular Access Catheter comes in usable lengths of 95, 105 or 115cm. The SelectFlex Neurovascular Access Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex Neurovascular Access Catheter comes in two options of a short hydrophilic coating length of 11.5cm or a long hydrophilic coating length of 30cm.

The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.

The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of: - . 087 Balloon Guide Catheter - 1cc Inflation Syringe ● - 8Fr Peel Away Introducer ● - Hub Extension - Three Way Stopcock ● The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.

The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The SelectFlex 072 Neurovascular Access System is a sterile, single-use intravascular catheter used to facilitate access to target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, a 7Fr Peel Away Introducer, and Hub Extension Line. The 072 SelectFlex Catheter has a usable length of 105cm. The SelectFlex 072 Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex 072 Catheter has a hydrophilic coating.

The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures.

The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of: - 087 Balloon Guide Catheter - 1cc Inflation Syringe - 8Fr Peel Away Introducer - Hub Extension - Three Way Stopcock The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Neurovascular Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.

The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The SelectFlex 072 Neurovascular Access System is a sterile, single-use intravascular catheter used to facilitate access target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, and a 7Fr Peel Away Introducer. The 072 SelectFlex Catheter has a usable length of 105cm. The SelectFlex 072 Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex 072 Catheter has a hydrophilic coating.