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510(k) Data Aggregation

    K Number
    K030443
    Device Name
    MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
    Date Cleared
    2003-05-09

    (87 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    NASTECH PHARMACEUTICAL COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MASCT device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
    Device Description
    The Nastech MASCT device is similar to the non-powered breast aspirators manufactured by Nastech Pharmaceutical Company, Inc. and Pro-Duct Health, Inc. used to elicit and collect nipple aspirate fluid (NAF) from the excretory ducts (tubuli lactiferi or galactophori). The device is comprised of a rigid polycarbonate cup in which the sample collection container is inserted. Negative pressure (vacuum) is produced by nonpowered (hand) actuations of a lever like handle. The expressed NAF sample is collected on a membrane filter and washed into the sample container using an appropriate fixative solution.
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    K Number
    K012088
    Device Name
    NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
    Date Cleared
    2001-12-18

    (168 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    NASTECH PHARMACEUTICAL COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MASCT device is intended for use in the collection of nipple aspirate fluid for laboratory cytological testing.
    Device Description
    The Nastech MASCT device is similar to the non-powered breast pumps Manufactured by Windy Hill Technology used to elicit and collect nipple aspirate fluid (NAF) from the excretory ducts (tubuli lactiferi or galactophori). The device is comprised of a rigid polycarbonate cup in which the sample collection container is inserted. Negative pressure (vacuum) is produced by non-powered (hand) actuations of a lever like handle. The expressed NAF sample is collected on a membrane filter and washed into the sample container using an appropriate fixative solution.
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    Ask a specific question about this device

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