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The Plato 17 Microcatheter is intended for the introduction of embolic coils and infusion of diagnostic agents, such as contrast media, to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.

Scientia Vascular's Plato® 17 Microcatheter is a single lumen, open-ended catheter designed to be flexible and axially stable, to aid the physician in the accessing of distal vasculature. The Plato 17 Microcatheter is supplied sterile and is for single use only. The Plato 17 Microcatheter is packaged with various tip configurations, including straight and pre-shaped (45° and 90°). The microcatheter shaft design includes nitinol, polymers of varying durometer and an internal liner providing lubricity for intraluminal delivered embolic coils and contrast media: the distal exterior section of the catheter shaft is hydrophilic coated to reduce friction during manipulation in vessels. The working length of the catheter is 160 cm. The microcatheter includes two radiopague tip markers to facilitate fluoroscopic visualization and a clear hub with luer lock and a strain relief. The Plato 17 Microcatheter is compatible with 0.014 inch guidewires or embolic coils. The microcatheter is provided with a steam shaping mandrel, peel-away introducer and a ruler. The shaping mandrel, peel-away introducer and ruler are accessories included to facilitate use of the microcatheter and are not intended to contact the patient's body.

The Zoom 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Zoom 14 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: support and extra support. The product is provided in lengths of 200cm or 300cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels. The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle 24 Guidewire is a modification of Scientia Vascular's Aristotle 18 Guidewire. It is a 0.024" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels. The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle 18 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.018" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels. The guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The Volo 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Volo 14 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles, from soft to standard. The product is provided in 200cm and 300cm lengths. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels. The guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The Aristotle 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Scientia Vascular Aristotle 14 Guidewire is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles, from soft to support, The product is provided in 200cm and 300cm lengths. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels. The guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The Plato MICROCATH 27B Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic agents to the peripheral and neurovascular systems. The catheter is also intended for the introduction of therapeutic agents to the peripheral system. The catheter is not intended for use in the coronary vasculature.

The Plato MICROCATH® 27B Microcatheter is a single lumen microcatheter with a flexible polymer shaft of varying stiffness to aid in navigation of the neurovasculature. The catheter is designed to be used with a guide catheter and a steerable guidewire. The proximal end of the catheter has a diameter of 3.4F tapering to a distal OD of 3.2F. The catheter can be inserted into a 5F guide catheter. The inner diameter is constant over the entire length of the catheter shaft and accommodates guidewires up to 0.025" in diameter. The catheter is 150 cm in length with a straight tip configuration which can be shaped, using steam heat and the provided mandrels, to the users' preferred shapes. A steam shaping mandrel is included in the packaging. The microcatheter has a hydrophilic coating on the outer distal shaft to reduce friction during catheter manipulation in the vasculature and has one radiopaque tip marker at its distal tip to facilitate fluoroscopic visualization. The subject microcatheter is identical with respect to its technological characteristics, design and materials to Scientia's currently marketed Plato MICROCATH 27B Microcatheters cleared under K143398. This 510k was prepared to expand the indications for use of the device to include its use in the neurovasculature.