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

    EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO

    K Number: K091140 · Decision Oct 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    19
    Review Days
    177

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    Basic Information

    Device Name
    EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
    K Number
    K091140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vidacare Corporation
    Date Received
    April 20, 2009
    Decision Date
    October 14, 2009
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Vidacare Corporation

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    K113872 THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
    K101026 POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
    K081713 VERTEBRAL ACCESS SYSTEM BY VIDACARE
    K072045 ONCONTROL BONE MARROW BIOPSY SYSTEM
    K070759 POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
    K063567 EZ-MIO STERNAL
    K063142 MANUAL PD-IO; POWERED PD-IO
    K062956 EZ-MIO, EZ-IO DISTAL TIBIA
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