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

    SCANLAN (TM) VEIN/GRAFT HOLDER

    K Number: K864919 · Decision Jan 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    19
    Review Days
    27

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    Basic Information

    Device Name
    SCANLAN (TM) VEIN/GRAFT HOLDER
    K Number
    K864919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4650
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Scanlan Intl., Inc.
    Date Received
    December 16, 1986
    Decision Date
    January 12, 1987
    Product Code
    KPK
    Advisory Committee
    General, Plastic Surgery
    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
    KPK Marker, Ostia, Aorto-Saphenous Vein

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    K911184 SCANLAN/TAHERI VALVULOTOME
    K864920 SCANLAN (TM) INSTRUMENT TRAY
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    K841521 SCANLAN ENDARSECTOR
    K841513 SCANLAN ATRAUM INSTRUMENT JAW COVER
    K841085 SCANLAN COLORMARK SKIN MARKER
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