BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC

    K Number: K931386 · Decision May 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    53
    Review Days
    70

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    Basic Information

    Device Name
    HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
    K Number
    K931386
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Meadox Medicals, Div. Boston Scientific Corp.
    Date Received
    March 18, 1993
    Decision Date
    May 27, 1993
    Product Code
    DXZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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