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

    USCI DOPPLER CATHETER SYSTEM

    K Number: K810414 · Decision Aug 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    71
    Applicant Total
    645
    Review Days
    175

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    Basic Information

    Device Name
    USCI DOPPLER CATHETER SYSTEM
    K Number
    K810414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2880
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    C.R. Bard, Inc.
    Date Received
    February 18, 1981
    Decision Date
    August 12, 1981
    Product Code
    JOP
    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
    JOP Transducer, Ultrasonic

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