BEUDAMED
    Product Code: PJQ FDA class 3

    Agent, Occluding, Vascular, Permanent

    Unknown

    The Permanent Vascular Occluding Agent is a polymerizing agent device intended for the permanent occlusion of peripheral blood vessels, used in interventional radiology and vascular surgery to block abnormal or unwanted blood flow. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA) due to the permanent and irreversible nature of vascular occlusion, reviewed by the Cardiovascular (CV) panel. The product code is PJQ, and it is flagged as an implant. No regulation number or medical specialty has been formally assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PJQ
    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

    The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.