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510(k) Data Aggregation

    K Number
    K043515
    Device Name
    GRAFTSAVER
    Manufacturer
    VESCARE, INC.
    Date Cleared
    2005-03-31

    (101 days)

    Product Code
    GBX
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    VESCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use in the distention and irrigation of venous vessels prior to use as a bypass graft.
    Device Description
    The device is comprised of 10 biocompatible components including a syringe stopper, a oring and rod, a green acetal ring, a black acetal pusher, a white acetal knob and body. The device is packaged in a Tyvek blister peel pouch. The device is used for the preparation and irrigation of venous vessels prior to use as a bypass graft. The device has three settings which allow the user to limit the nominal pressure up to 150 mmHg, 250 mmHg or 350 mmHg.
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