BEUDAMED
    Product Code: QZI FDA class 3

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    Unknown

    The percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation (product code QZI) is a Class 3 Cardiovascular device reviewed by the Cardiovascular panel, intended for the treatment of atrial fibrillation using irreversible electroporation energy to ablate cardiac tissue. As a Class 3 device, it requires PMA. 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
    37
    Registration Numbers
    37
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QZI
    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 the treatment of atrial fibrillation.

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.