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

    THEROX INFUSION GUIDEWIRES

    K Number: K971719 · Decision Nov 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    2
    Review Days
    178

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    Basic Information

    Device Name
    THEROX INFUSION GUIDEWIRES
    K Number
    K971719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Therox, Inc.
    Date Received
    May 9, 1997
    Decision Date
    November 3, 1997
    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 Therox, Inc.

    K Number Device Name
    K052637 THEROX INFUSION CATHETER, MODEL INCA-1