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

    SCANLAN ENDARSECTOR

    K Number: K841521 · Decision Aug 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    13
    Applicant Total
    19
    Review Days
    113

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    Basic Information

    Device Name
    SCANLAN ENDARSECTOR
    K Number
    K841521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Scanlan Intl., Inc.
    Date Received
    April 12, 1984
    Decision Date
    August 3, 1984
    Product Code
    DWX
    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
    DWX Stripper, Artery, Intraluminal

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    Other Clearances by Scanlan Intl., Inc.

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    K911184 SCANLAN/TAHERI VALVULOTOME
    K864920 SCANLAN (TM) INSTRUMENT TRAY
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    K851825 SCANLAN TUNNELER, SHEATH & TIP
    K841513 SCANLAN ATRAUM INSTRUMENT JAW COVER
    K841085 SCANLAN COLORMARK SKIN MARKER
    K841515 SCANLAN VASCU-STATT II
    K841514 SCANLAN VASCU-STATT II APPROXIMATOR
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