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510(k) Data Aggregation

    K Number
    K220398
    Device Name
    Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
    Manufacturer
    Scientia Vascular, LLC
    Date Cleared
    2023-03-10

    (392 days)

    Product Code
    MOF, DAT, DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Scientia Vascular, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 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 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 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 Zoom Wire 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.
    Device Description
    The Scientia Vascular's Aristotle 14, Aristotle 24, Volo 14, and Zoom Wire 14 Guidewires ("the guidewires") are steerable guidewires with a shapeable tip to aid in accessing the neuro and peripheral vasculatures. The guidewires are supplied sterile, for single use only, in the following diameters, stiffness profiles, and lengths: Aristotle 14 Guidewire: Diameter 0.014", Stiffness Profiles Soft, Standard, Lengths 200 cm, 300 cm Aristotle 18 Guidewire: Diameter 0.018", Stiffness Profiles Soft, Standard, Support, Length 200 cm Aristotle 24 Guidewire: Diameter 0.024", Stiffness Profiles Soft, Standard, Support, Length 200 cm Volo 14 Guidewire: Diameter 0.014", Stiffness Profiles Soft, Standard, Lengths 200 cm, 300 cm Zoom Wire 14 Guidewire: Diameter 0.014", Stiffness Profiles Support, Extra Support, Lengths 200 cm, 300 cm The distal portion of each guidewire's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. All guidewires have 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 guidewires are provided with an accessory kit consisting of an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve), a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use), and a shaping mandrel (to aid in shaping the flexible tip of the guidewire). These accessory devices are included to facilitate use of the guidewires and are not intended to contact the patient's body.
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