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

    ACS HI-TORQUE GUIDE WIRES

    K Number: K874202 · Decision Apr 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    252
    Registration Numbers
    253
    Same Product Code
    751
    Applicant Total
    103
    Review Days
    196

    Basic Information

    Device Name
    ACS HI-TORQUE GUIDE WIRES
    K Number
    K874202
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Date Received
    October 15, 1987
    Decision Date
    April 28, 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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