BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Trapper Exchange Device

    K Number: K162253 · Decision Jan 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    2
    Review Days
    149

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    Basic Information

    Device Name
    Trapper Exchange Device
    K Number
    K162253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Creganna Medical Aslo Business AS Cregganna Tactx Medical
    Date Received
    August 10, 2016
    Decision Date
    January 6, 2017
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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    Other Clearances by Creganna Medical Aslo Business AS Cregganna Tactx Medical

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