BEUDAMED
    Product Code: QYI FDA class 3

    Ablation Catheter, Renal Denervation

    Unknown

    The ablation catheter for renal denervation (product code QYI) is a Class 3 Cardiovascular device reviewed by the Cardiovascular panel, intended for denervating the renal nerves to lower blood pressure. As a Class 3 device, it requires PMA due to the high-risk nature of renal nerve ablation procedures. No regulation number has been assigned. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QYI
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    For denervating the renal nerves to lower blood pressure

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.