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

    CORONARY SINUS ACCESS KIT, MODEL KCS8F-01

    K Number: K050808 · Decision Jul 28, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    120

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    Basic Information

    Device Name
    CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
    K Number
    K050808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardio-Optics, Inc.
    Date Received
    March 30, 2005
    Decision Date
    July 28, 2005
    Product Code
    LYK
    Advisory Committee
    Gastroenterology, Urology
    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
    LYK Angioscope

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    Other Clearances by Cardio-Optics, Inc.

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