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

    GUIDING CATHETER (TIP SOFTNESS CHANGE)

    K Number: K883981 · Decision Nov 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    14
    Review Days
    43

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    Basic Information

    Device Name
    GUIDING CATHETER (TIP SOFTNESS CHANGE)
    K Number
    K883981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Devices For Vascular Intervention, Inc.
    Date Received
    September 21, 1988
    Decision Date
    November 3, 1988
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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