BEUDAMED
    Product Code: LPB FDA class 3

    Cardiac Ablation Percutaneous Catheter

    Unknown

    The Cardiac Ablation Percutaneous Catheter is a device used to treat cardiac arrhythmias by delivering energy (such as radiofrequency energy) through a catheter advanced percutaneously to the heart to ablate abnormal electrical pathways. This product code pertains to cardiac ablation catheters indicated for general indications and for the treatment of supraventricular arrhythmias. It is classified as a Class 3 (highest risk) device, requiring Premarket Approval (PMA) prior to marketing. The product code is LPB; no specific regulation number or medical specialty code is recorded, though the review panel is Cardiovascular (CV). No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    52
    Registration Numbers
    52
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    LPB
    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

    This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].

    FEI Numbers

    This FDA classification entry is associated with 52 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 52 registration numbers. Click on an entry to view related FDA registrations.