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

    C.A.B. RING

    K Number: K894268 · Decision Aug 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    56

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    Basic Information

    Device Name
    C.A.B. RING
    K Number
    K894268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medi-Sharp, Inc.
    Date Received
    June 22, 1989
    Decision Date
    August 17, 1989
    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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