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

    TRU-TRAC TORQUE GUIDEWIRE

    K Number: K880288 · Decision Sep 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    5
    Review Days
    231

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    Basic Information

    Device Name
    TRU-TRAC TORQUE GUIDEWIRE
    K Number
    K880288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    N-S Medical Products
    Date Received
    January 25, 1988
    Decision Date
    September 12, 1988
    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 N-S Medical Products

    K Number Device Name
    K880287 TRU-TRAC COILED GUIDEWIRE
    K881956 NATIONAL-STANDARD NEEDLE HOLDER
    K881957 HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT
    K870523 HAWKINS BREAST LOCALIZATION NEEDLE