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

    BAERVELT PARS PLANA GLAUCOMA IMPLANT

    K Number: K955455 · Decision Feb 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    447

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    Basic Information

    Device Name
    BAERVELT PARS PLANA GLAUCOMA IMPLANT
    K Number
    K955455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3920
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pharmacia Iovision, Inc.
    Date Received
    November 29, 1995
    Decision Date
    February 18, 1997
    Product Code
    KYF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KYF Implant, Eye Valve

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