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

    Reverse Medical Micro Vascular Plug System

    K Number: K150108 · Decision Apr 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    122
    Applicant Total
    10
    Review Days
    92

    Basic Information

    Device Name
    Reverse Medical Micro Vascular Plug System
    K Number
    K150108
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    REVERSE MEDICAL CORPORATION
    Date Received
    January 20, 2015
    Decision Date
    April 22, 2015
    Product Code
    KRD
    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
    KRD Device, Vascular, For Promoting Embolization

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