BEUDAMED
    Product Code: DQP FDA class 3 21 CFR 870.1350

    Kit, Balloon Repair, Catheter

    Cardiovascular

    The Balloon Repair Catheter Kit is a cardiovascular device kit used in the repair or replacement of balloon components of intravascular catheters, typically applied in angioplasty or other balloon-catheter procedures. It is classified as an FDA Class 3 device, the highest risk category, and requires Premarket Approval (PMA) before marketing. The product code is DQP and it is regulated under 21 CFR 870.1350 within the Cardiovascular medical specialty. A call for PMAs was issued on 12/26/96 (61 FR 50706).

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    Basic Information

    Product Code
    DQP
    Device Class
    FDA class 3
    Regulation Number
    870.1350
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

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

    Definition

    Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))