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

    HYBRID Guidewire

    K Number: K182337 · Decision Oct 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    39
    Applicant Total
    18
    Review Days
    37

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    Basic Information

    Device Name
    HYBRID Guidewire
    K Number
    K182337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Balt USA, LLC
    Date Received
    August 28, 2018
    Decision Date
    October 4, 2018
    Product Code
    MOF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    MOF Guide, Wire, Catheter, Neurovasculature

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