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

    esolution

    K Number: DEN230006 · Decision Sep 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    225

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    Basic Information

    Device Name
    esolution
    K Number
    DEN230006
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.5710
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    S4 Medical Corp.
    Date Received
    January 24, 2023
    Decision Date
    September 6, 2023
    Product Code
    QXU
    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
    QXU Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QXU), ordered by most recent decision date.

    esolution® Esophageal Retractor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
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    Other Clearances by S4 Medical Corp.

    K Number Device Name
    K243233 esolution® Esophageal Retractor