BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F

    K Number: K110193 · Decision Feb 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    5
    Review Days
    31

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    Basic Information

    Device Name
    FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F
    K Number
    K110193
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    St. Jude Medical Systems AB
    Date Received
    January 24, 2011
    Decision Date
    February 24, 2011
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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