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510(k) Data Aggregation

    K Number
    K093822
    Device Name
    DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY
    Manufacturer
    SHEPHERD SCIENTIFIC INC
    Date Cleared
    2010-01-28

    (45 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEPHERD SCIENTIFIC INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AngioAssist is a set of manual instruments intended to facilitate alignment and introduction of interventional devices (i.e., guide wires and catheters) within the coronary and peripheral vasculature.
    Device Description
    The AngioAssist consists of the Docking Station , Teirstein Edge and AngioAssist Combination Device. The devices are provided sterile for single use.
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