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

    WALLSTENT ENTERAL ENDOPROTHESIS

    K Number: K954290 · Decision Jul 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    35
    Review Days
    300

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    Basic Information

    Device Name
    WALLSTENT ENTERAL ENDOPROTHESIS
    K Number
    K954290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Scimed, Inc.
    Date Received
    September 14, 1995
    Decision Date
    July 10, 1996
    Product Code
    MQR
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQR Stent, Colonic, Metallic, Expandable

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    Other Clearances by Boston Scientific Scimed, Inc.

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    K021901 WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
    K012822 MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
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    K000743 BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
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