BEUDAMED
    Product Code: QKJ FDA class 3

    Stent, Central Venous

    Unknown

    The Stent, Central Venous is a Class 3 cardiovascular implant device intended as a prescription device for maintaining the luminal diameter of the central veins, used in patients with central venous stenosis or occlusion. It requires Premarket Approval (PMA), reviewed by the Cardiovascular panel, with no regulation number assigned. The product code is QKJ, and the device carries an implant flag as it is permanently placed within the venous system. It is not flagged as life-sustaining.

    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
    QKJ
    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

    A central venous stent is a prescription device for maintaining the luminal diameter of the central veins.

    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.