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    K Number
    K070661
    Device Name
    VITALCOR FEATHERWEIGHT VASCULAR CLAMPS
    Manufacturer
    VITALCOR, INC.
    Date Cleared
    2007-08-29

    (173 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These titanium clamps are used for temporarily occlusion of blood vessels during surgery.
    Device Description
    Vitalcor Featherweight clamps are made from Grade 5 titanium, Vitalcor Featherweight clamps are calibrated to have a clamping pressure that will minimize the possibility of vessel damage. As a guide, the following Vitalcor Featherweight sizes should be used for the vessels size range indicated. VA079-06 0.4mm-1.0mm . . VA115−09 0.6mm−1.5mm VA140-09 1mm-2mm . VA240-18 1.5mm-3mm . VA300-24 2mm-4mm . VA375-30 3mm-5mm .
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    K Number
    K030231
    Device Name
    CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
    Manufacturer
    VITALCOR, INC.
    Date Cleared
    2003-04-18

    (86 days)

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

    VITALCOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coronary Artery Perfusion Cannula with Self-Inflating Balloon is indicated for use in delivery of cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass surgery.
    Device Description
    The Coronary Artery Perfusion Cannula with Self-Inflating Balloon consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tubing for purposes of receiving the infused cardioplegia solution. The subject device is provided for in five sizes based upon the diameter of the cuff consisting of 4, 5, 6, 7 & 8 mm in diameter. Furthermore, the cannula is pre-shaped into two configurations both straight and right angle.
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