BEUDAMED
    Product Code: OAD FDA class 3

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    Unknown

    The Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter (product code OAD) is an interventional cardiology catheter used in catheter ablation procedures to treat atrial flutter by delivering energy to create lesions that interrupt abnormal electrical conduction pathways in the heart. It is classified as FDA Class 3, requiring Premarket Approval (PMA), and is reviewed by the Cardiovascular panel. This device carries a life-sustaining flag given its role in treating a serious cardiac arrhythmia.

    View on FDA
    510(k)s
    0
    FEI Numbers
    46
    Registration Numbers
    46
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    OAD
    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 flutter.

    FEI Numbers

    This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.