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

    VARIABLE STIFFNESS WIRE GUIDE

    K Number: K781393 · Decision Oct 30, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    190
    Review Days
    81

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    Basic Information

    Device Name
    VARIABLE STIFFNESS WIRE GUIDE
    K Number
    K781393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cook, Inc.
    Date Received
    August 10, 1978
    Decision Date
    October 30, 1978
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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