BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES

    K Number: K094018 · Decision Apr 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    184
    Applicant Total
    5
    Review Days
    108

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    Basic Information

    Device Name
    LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
    K Number
    K094018
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biocompatibles UK Limited
    Date Received
    December 29, 2009
    Decision Date
    April 16, 2010
    Product Code
    HCG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCG Device, Neurovascular Embolization

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    Other Clearances by Biocompatibles UK Limited

    K Number Device Name
    K162373 LC Bead LUMI
    K083091 LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
    K042231 GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
    K033761 GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES