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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.