BEUDAMED
    Product Code: QRH FDA class 3

    Catheter, Balloon, Urethral, Drug-Coated

    Unknown

    The Drug-Coated Urethral Balloon Catheter is a percutaneous catheter device used to dilate urethral strictures, with a drug-coating intended to reduce recurrence following dilation. The combination of an active drug coating and the balloon catheter places this device in the highest risk category. Classified as FDA Class 3 requiring Premarket Approval (PMA) and reviewed under the Gastroenterology and Urology panel, it has no assigned regulation number. The device is not flagged as an implant or life-sustaining.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QRH
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

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

    Definition

    Dilate urethral strictures

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.