BEUDAMED
    Product Code: LMQ FDA class 3

    Device, Peritoneal Access, Subcutaneous, Implanted

    Unknown

    Device, Peritoneal Access, Subcutaneous, Implanted is a totally implantable device used to provide repeated long-term access to the peritoneal cavity through a subcutaneous port, used for procedures such as continuous peritoneal dialysis or intraperitoneal drug delivery. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA). The product code is LMQ; no regulation number has been assigned, and the review panel is General Hospital. This device is an implant.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LMQ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    HO
    Submission Type
    3

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K854593 NORFOLK MEDICAL PERITONEAL-ACCESS PORT