BEUDAMED
    Product Code: MLV FDA class 3

    Transcatheter Septal Occluder

    Unknown

    The Transcatheter Septal Occluder is an implantable device delivered via catheter to close intracardiac septal defects such as patent foramen ovale (PFO) or atrial septal defect (ASD), blocking the abnormal communication between cardiac chambers to prevent paradoxical embolism or reduce hemodynamic burden. It is a Class 3 implantable device that received PMA approval (P000039) and is also designated as life-sustaining, reflecting the critical nature of its cardiac application. It carries both implant and life-sustaining flags.

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    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MLV
    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

    Approved PMA: P000039

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.