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510(k) Data Aggregation

    K Number
    K162565
    Device Name
    VIA 17 Microcatheter
    Manufacturer
    SEQUENT MEDICAL, INC.
    Date Cleared
    2017-02-18

    (157 days)

    Product Code
    DQY, KRA
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEQUENT MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VIA™ 17 Microcatheter is intended for the introduction of non-liquid interventional devices (such as coils/ stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral and coronary vasculature.
    Device Description
    The VIA™ 17 Microcatheter is a sterile single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as coils/stents. The VIATM 17 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.0175 inches. The VIA™ 17 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic. Accessories: Each VIA™ 17 Microcatheter is provided with shaping mandrels to facilitate distal tip shaping. In intravascular procedures, the device assists the physician in: - Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as coils and stents, and infusion of diagnostic agents such as contrast.
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