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

    PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER

    K Number: K894286 · Decision Oct 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    63
    Applicant Total
    20
    Review Days
    111

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    Basic Information

    Device Name
    PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
    K Number
    K894286
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2870
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ppg Industries, Inc.
    Date Received
    June 23, 1989
    Decision Date
    October 12, 1989
    Product Code
    DXO
    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
    DXO Transducer, Pressure, Catheter Tip

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