BEUDAMED
    Product Code: PRC FDA class 3

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    Unknown

    The Drug-Coated Peripheral Transluminal Angioplasty Catheter is a balloon catheter coated with a drug (such as paclitaxel) used for dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency in patients with vascular access dysfunction. It is classified as FDA Class 3, requiring Premarket Approval (PMA) due to the high risk associated with its drug-device combination in the vasculature. The device is reviewed by the Cardiovascular panel. Product code PRC; no regulation number assigned; not an implant and not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PRC
    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

    Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.