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

    SUTURING WASHER

    K Number: K052642 · Decision Jan 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    113

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    Basic Information

    Device Name
    SUTURING WASHER
    K Number
    K052642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    First Call, Inc.
    Date Received
    September 26, 2005
    Decision Date
    January 17, 2006
    Product Code
    MAB
    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
    MAB Marker, Cardiopulmonary Bypass (Vein Marker)

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