BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    DuraSheath Introducer Sheath System

    K Number: K142357 · Decision Jun 25, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    268
    Registration Numbers
    268
    Same Product Code
    682
    Applicant Total
    2
    Review Days
    304

    Basic Information

    Device Name
    DuraSheath Introducer Sheath System
    K Number
    K142357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CONTRACT MEDICAL INTERNATIONAL GMBH
    Date Received
    August 25, 2014
    Decision Date
    June 25, 2015
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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