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

    BEARING NSPVA EMBOLIZATION PARTICLES

    K Number: K130259 · Decision Jun 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    7
    Applicant Total
    178
    Review Days
    126

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    Basic Information

    Device Name
    BEARING NSPVA EMBOLIZATION PARTICLES
    K Number
    K130259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    February 1, 2013
    Decision Date
    June 7, 2013
    Product Code
    NAJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NAJ Agents, Embolic, For Treatment Of Uterine Fibroids

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