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

    SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM

    K Number: K960372 · Decision Apr 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    35
    Applicant Total
    19
    Review Days
    91

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    Basic Information

    Device Name
    SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
    K Number
    K960372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scanlan Intl., Inc.
    Date Received
    January 26, 1996
    Decision Date
    April 26, 1996
    Product Code
    HCH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCH Clip, Aneurysm

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    Other Clearances by Scanlan Intl., Inc.

    K Number Device Name
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    K911184 SCANLAN/TAHERI VALVULOTOME
    K864920 SCANLAN (TM) INSTRUMENT TRAY
    K864919 SCANLAN (TM) VEIN/GRAFT HOLDER
    K851825 SCANLAN TUNNELER, SHEATH & TIP
    K841521 SCANLAN ENDARSECTOR
    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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