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

    Z FLEX-270TM STEERABLE SHEATH

    K Number: K112541 · Decision Feb 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    40
    Applicant Total
    10
    Review Days
    159

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    Basic Information

    Device Name
    Z FLEX-270TM STEERABLE SHEATH
    K Number
    K112541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Great Batch Medical
    Date Received
    September 1, 2011
    Decision Date
    February 7, 2012
    Product Code
    DRA
    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
    DRA Catheter, Steerable

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