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510(k) Data Aggregation

    K Number
    K990447
    Device Name
    1000 PRESSURE INFUSION SIGMACON 1000
    Manufacturer
    VALLEY WEST, INC.
    Date Cleared
    1999-05-12

    (89 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    VALLEY WEST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General surgical fluid irrigation and infiltration.
    Device Description
    The principles of operation and technology incorporated in the 1000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff to apply direct pressure externally to a bag of fluid for infusion of fluids).
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    K Number
    K980089
    Device Name
    3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000
    Manufacturer
    VALLEY WEST, INC.
    Date Cleared
    1998-03-24

    (74 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    VALLEY WEST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3600 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.
    Device Description
    The principles of operation and technology incorporated in the 3600 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff to apply direct pressure externally to a bag of fluid for infusion of fluids.
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    K Number
    K973814
    Device Name
    TRUMP-IT II AND MAGNUM 250
    Manufacturer
    VALLEY WEST, INC.
    Date Cleared
    1998-01-30

    (115 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VALLEY WEST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use in patients eligible for treatment via general laparoscopic surgical procedures.
    Device Description
    The Candidate Device consists of a hand-held trumpet valve suction-irrigator designed to provide pinpoint suction and irrigation to the surgical site during general laparoscopic procedures. This device is designed for use with legally-marketed irrigation pumps, irrigant bags and bottles, and legallymarketed suction sources.
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