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

    DacryoCATH

    K Number: K142914 · Decision Jan 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    21
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    97

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    Basic Information

    Device Name
    DacryoCATH
    K Number
    K142914
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Armadillo Biomedical, LLC
    Date Received
    October 7, 2014
    Decision Date
    January 12, 2015
    Product Code
    OKS
    Advisory Committee
    Unknown
    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
    OKS Lacrimal Stents And Intubation Sets

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    Other Clearances by Armadillo Biomedical, LLC

    K Number Device Name
    K113508 DACRYOCATH