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510(k) Data Aggregation

    K Number
    K003115
    Device Name
    ACTIS ADJUSTABLE CONSTRICTION LOOP
    Manufacturer
    VIVUS, INC.
    Date Cleared
    2000-12-19

    (78 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962915
    Device Name
    ACTIS (VENOUS FLOW CONTROLLER)
    Manufacturer
    VIVUS, INC.
    Date Cleared
    1996-12-10

    (137 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACTIS® (Venous Flow Controller) device is an erection enhancement device that is designed to slow venous outflow from the penis and thus aid in the normal erection process.
    Device Description
    It is a linear elastic tube with an O ring and ball locking unit that allows ease of adjustment to increase or decrease tension. Placement is around the base of the penis.
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