BEUDAMED
    Product Code: MGB FDA class 3

    Device, Hemostasis, Vascular

    Unknown

    The vascular hemostasis device is a cardiovascular device used to achieve hemostasis at vascular access sites following catheterization procedures, reducing bleeding complications and time to ambulation. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MGB and no regulation number or formal medical specialty has been assigned. The device is not an implant and does not sustain life.

    View on FDA
    510(k)s
    0
    FEI Numbers
    33
    Registration Numbers
    33
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MGB
    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

    FEI Numbers

    This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.