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

    MODIFIED TREVO RETRIEVER

    K Number: K122478 · Decision Oct 31, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    108
    Applicant Total
    45
    Review Days
    78

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    Basic Information

    Device Name
    MODIFIED TREVO RETRIEVER
    K Number
    K122478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Concentric Medical, Inc.
    Date Received
    August 14, 2012
    Decision Date
    October 31, 2012
    Product Code
    NRY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NRY Catheter, Thrombus Retriever

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    Other Clearances by Concentric Medical, Inc.

    K Number Device Name
    K173352 Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
    DEN150049 Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
    K150616 Trevo XP ProVue Retriever (4x30mm)
    K143077 Trevo XP ProVue Retriever (6X25mm)
    K133177 MODIFIED HD GUIDE CATHETER
    K133464 MODIFIED TREVO PROVUE RETRIEVER
    K132641 MODIFIED TREVO PROVUE RETRIEVER
    K131437 MODIFIED CONCENTRIC MICROCATHETER
    K131492 MODIFIED FLOWGATE BALLOON GUIDE CATHETER
    K122581 MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
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