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

    HEMOSTATIC SIDE-ARM ADAPTER

    K Number: K813578 · Decision Jan 18, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    5
    Review Days
    26

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    Basic Information

    Device Name
    HEMOSTATIC SIDE-ARM ADAPTER
    K Number
    K813578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Advanced Catheter Systems
    Date Received
    December 23, 1981
    Decision Date
    January 18, 1982
    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 Advanced Catheter Systems

    K Number Device Name
    K813577 PRESSURE INDICATOR-REGULATOR
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