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

    TEFLON COATED GUIDEWIRE

    K Number: K902153 · Decision Jul 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    3
    Review Days
    76

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    Basic Information

    Device Name
    TEFLON COATED GUIDEWIRE
    K Number
    K902153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Guidewire Technologies, Inc.
    Date Received
    May 16, 1990
    Decision Date
    July 31, 1990
    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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    Other Clearances by Guidewire Technologies, Inc.

    K Number Device Name
    K902152 MOVABLE CORE GUIDEWIRE
    K890959 GUIDEWIRE