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

    ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER

    K Number: K122027 · Decision Aug 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    154
    Applicant Total
    19
    Review Days
    48

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    Basic Information

    Device Name
    ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
    K Number
    K122027
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5140
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrow International, Inc.
    Date Received
    July 11, 2012
    Decision Date
    August 28, 2012
    Product Code
    CAZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAZ Anesthesia Conduction Kit

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