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510(k) Data Aggregation

    K Number
    K170488
    Device Name
    Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr
    Manufacturer
    Surge Cardiovascular
    Date Cleared
    2017-08-10

    (174 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surge Cardiovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Peak Left Ventricular Vent Cannula is indicated for use in venting the left ventricle during cardiopulmonary bypass procedures for durations up to 6 hours. The entrance is made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.
    Device Description
    The Peak Left Ventricular Vent Cannula is a single lumen, PVC cannula intended for use in venting the left ventricle during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve. The 36cm Cannula has an open end at the distal tip and a series of side holes at the distal end of the cannula to allow for venting when inserted into the left ventricle. The device is designed with an open-ended smooth, tapered tip to minimize trauma to the tissues. The cannula body slip connector allows for connection to ¼" tubing for venting by the physician. The device is supplied with a malleable PVC Introducer which has a length of stainless steel wire enclosed within the Introducer sheath. The Introducer has a smooth rounded tip at the distal end. When the Introducer is inserted into the cannula body, the luer hub fits into the internal diameter of the slip connector. When the luer hub is seated in the cannula slip connector, the smooth rounded end of the introducer extends beyond the open tip of the Cannula. The device is provided sterile and is intended for single-use.
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