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

    ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM

    K Number: K060239 · Decision Mar 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    55
    Applicant Total
    9
    Review Days
    50

    Basic Information

    Device Name
    ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
    K Number
    K060239
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ALVEOLUS, INC.
    Date Received
    January 31, 2006
    Decision Date
    March 22, 2006
    Product Code
    ESW
    Advisory Committee
    General, Plastic Surgery
    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
    ESW Prosthesis, Esophageal

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    Other Clearances by ALVEOLUS, INC.

    K Number Device Name
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    K062511 AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
    K051621 ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
    K033990 ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    K033053 ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    K032744 ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    K030947 ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM