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510(k) Data Aggregation

    K Number
    K160721
    Device Name
    Vado Steerable Sheath
    Date Cleared
    2017-03-07

    (356 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    KALILA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vado Steerable Sheath is indicated for introducing various catheters into the vasculature and into the chambers of the heart including the left side of the heart through the interatrial septum.
    Device Description
    The Vado Steerable Sheath consists of an 8.8F (ID) sheath and dilator, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter exchange. A sideport with three-way stopcock is provided for aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a deflection knob, deflects the sheath tip. The steerable introducer features distal vent holes for aspiration and radiopaque markers to facilitate visualization under fluoroscopy.
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    K Number
    K162427
    Device Name
    Vado Bi-Directional Steerable Sheath
    Date Cleared
    2017-01-27

    (150 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    KALILA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vado® Bi-Directional Steerable Sheath is introducing various cardiovascular catheters into the vasculature and into the chambers of the heart including the heart through the interatrial septum.
    Device Description
    The Vado® Bi-Directional Steerable Sheath consists of a dilator and steerable sheath which are designed to provide intracardiac access and flexible, stable catheter positioning in the cardiac anatomy. A hemostasis valve in the handle minimizes blood loss during catheter introduction and/or exchange. A side port with 3-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A deflection knob on the handle deflects the tip of the sheath clockwise ≥ 180° and counterclockwise ≥ 90°. Distal tip vent holes facilitate aspiration and a radiopaque marker permits visualization of the sheath tip under fluoroscopy.
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    K Number
    K140420
    Device Name
    VADO STEERABLE SHEATH
    Date Cleared
    2014-04-01

    (42 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    KALILA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vado Steerable Sheath is indicated for introducing various cardiovascular catheters into the vasculature and into the chambers of the heart including the left side of the heart through the interatrial septum.
    Device Description
    The Kalila Vado Steerable Sheath consists of an 8.8F (ID) sheath and dilator, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter exchange. A sideport with three-way stopcock is provided for aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a deflection knob, deflects the tip 140°. The steerable introducer features distal vent holes for aspiration and radiopaque markers to facilitate visualization under fluoroscopy.
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