BEUDAMED
    Product Code: NAW FDA class 3

    Microspheres Radionuclide

    Unknown

    Radionuclide Microspheres are small radioactive particles used in radioembolization procedures, delivered via catheter into tumor-feeding blood vessels (particularly for hepatic tumors) to deliver localized radiation therapy while simultaneously embolizing the blood supply. An approved PMA exists for this device type (P990065). Classified as FDA Class 3, it requires Premarket Approval (PMA) due to the high-risk nature of internal radiation therapy. It is reviewed by the Radiology panel and carries the implant flag.

    View on FDA
    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NAW
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    RA
    Submission Type
    2

    Device Characteristics

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

    Definition

    Approved PMA: P990065

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.