BEUDAMED
    Product Code: DQG FDA class 3 21 CFR 870.1360

    Microsphere, Trace

    Cardiovascular

    The Trace Microsphere is a cardiovascular implantable device used to measure regional blood flow by introducing small spheres into the circulation as flow tracers during diagnostic or research 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 DQG and it is regulated under 21 CFR 870.1360 within the Cardiovascular medical specialty. A call for PMAs was issued on 12/26/96 (61 FR 50706). This device is flagged as an implant.

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    Basic Information

    Product Code
    DQG
    Device Class
    FDA class 3
    Regulation Number
    870.1360
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

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

    Definition

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