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

    REEKROSS FAMILY OR OTW PTA CATHETERS

    K Number: K083596 · Decision Mar 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    7
    Review Days
    87

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    Basic Information

    Device Name
    REEKROSS FAMILY OR OTW PTA CATHETERS
    K Number
    K083596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ClearStream Technologies , Ltd.
    Date Received
    December 5, 2008
    Decision Date
    March 2, 2009
    Product Code
    DQY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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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