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

    MODIFIED CONCENTRIC MICROCATHETER

    K Number: K131437 · Decision Oct 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    45
    Review Days
    144

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    Basic Information

    Device Name
    MODIFIED CONCENTRIC MICROCATHETER
    K Number
    K131437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Concentric Medical, Inc.
    Date Received
    May 20, 2013
    Decision Date
    October 11, 2013
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Concentric Medical, Inc.

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    K133177 MODIFIED HD GUIDE CATHETER
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    K131492 MODIFIED FLOWGATE BALLOON GUIDE CATHETER
    K122581 MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
    K122478 MODIFIED TREVO RETRIEVER
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