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510(k) Data Aggregation

    K Number
    K123264
    Device Name
    DK-PTCA BALLOON CATHETER
    Date Cleared
    2013-01-16

    (90 days)

    Product Code
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTUIT MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intuit Medical, LLC, DK-PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
    Device Description
    The DK-PTCA Balloon Catheter is a torqueable, rapid-exchange, percutaneous transluminal coronary angioplasty catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 6F guide catheters (MIN inner diameter of 0.074"). Catheter working length is approximately 142cm. The distal end of the catheter has a semi-compliant balloon that expands to known diameters and lengths at specific pressures. The balloon has two radiopaque markers to assist with positioning. The proximal end of the device is a common PTCA catheter design consisting of a hypo-tube connected to a plastic hub and strain relief and which assists with torque transmission. The hub is used to inflate the balloon and the luer connector is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip. The DK-PTCA Balloon Catheter is supplied sterile and intended for single use.
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