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

    PRESSURE INDICATOR-REGULATOR

    K Number: K813577 · Decision Jan 29, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    5
    Review Days
    37

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    Basic Information

    Device Name
    PRESSURE INDICATOR-REGULATOR
    K Number
    K813577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Advanced Catheter Systems
    Date Received
    December 23, 1981
    Decision Date
    January 29, 1982
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Advanced Catheter Systems

    K Number Device Name
    K813624 ADVANCED CATHETER SYSTEMS CORONARY GUID
    K813623 SIMPSON-ROBERT CORONARY GUIDING CATHET
    K813622 INDEFLATOR
    K813578 HEMOSTATIC SIDE-ARM ADAPTER