BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    LC Bead LUMI

    K Number: K162373 · Decision Dec 16, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    5
    Review Days
    114

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    Basic Information

    Device Name
    LC Bead LUMI
    K Number
    K162373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biocompatibles UK Limited
    Date Received
    August 24, 2016
    Decision Date
    December 16, 2016
    Product Code
    KRD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KRD Device, Vascular, For Promoting Embolization

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    Other Clearances by Biocompatibles UK Limited

    K Number Device Name
    K094018 LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
    K083091 LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
    K042231 GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
    K033761 GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES