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

    OUTBACK Elite Re-Entry Catheter

    K Number: K150836 · Decision Apr 29, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    56
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    OUTBACK Elite Re-Entry Catheter
    K Number
    K150836
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis Corporation, A Johnson & Johnson Co.
    Date Received
    March 30, 2015
    Decision Date
    April 29, 2015
    Product Code
    PDU
    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
    PDU Catheter For Crossing Total Occlusions

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