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

    Swang-Ganz IQ pulmonary artery catheter

    K Number: K222117 · Decision Dec 9, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    2
    Review Days
    144

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    Basic Information

    Device Name
    Swang-Ganz IQ pulmonary artery catheter
    K Number
    K222117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edwards Lifesiences, LLC
    Date Received
    July 18, 2022
    Decision Date
    December 9, 2022
    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 Edwards Lifesiences, LLC

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