BEUDAMED
    Product Code: NKO FDA class 3 21 CFR 870.3535

    System, Balloon, Intra-Aortic And Control, Reprocessed

    Cardiovascular

    The Reprocessed Intra-Aortic Balloon and Control System is a reprocessed cardiovascular device that uses counterpulsation to augment coronary perfusion and reduce cardiac workload; reprocessing validation data must be included in a 510(k) submission as required by FDA regulations. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NKO and regulation 21 CFR 870.3535 in the Cardiovascular specialty. The device is not flagged as an implant or life-sustaining in this classification record.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    NKO
    Device Class
    FDA class 3
    Regulation Number
    870.3535
    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

    Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).