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

    Corvocet Coaxial Introducer

    K Number: K151373 · Decision Aug 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    178
    Review Days
    78

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    Basic Information

    Device Name
    Corvocet Coaxial Introducer
    K Number
    K151373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    May 21, 2015
    Decision Date
    August 7, 2015
    Product Code
    FCG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FCG Biopsy Needle

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