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

    CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN

    K Number: K853383 · Decision Dec 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    5
    Review Days
    113

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    Basic Information

    Device Name
    CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
    K Number
    K853383
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Webster Laboratories, Inc.
    Date Received
    August 12, 1985
    Decision Date
    December 3, 1985
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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    Other Clearances by Webster Laboratories, Inc.

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