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

    VORTRAN Cuff Inflator (VCI)

    K Number: K173914 · Decision May 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    38
    Applicant Total
    28
    Review Days
    154

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    Basic Information

    Device Name
    VORTRAN Cuff Inflator (VCI)
    K Number
    K173914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5750
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vortran Medical Technology 1, Inc.
    Date Received
    December 22, 2017
    Decision Date
    May 25, 2018
    Product Code
    BSK
    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
    BSK Cuff, Tracheal Tube, Inflatable

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    Other Clearances by Vortran Medical Technology 1, Inc.

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    K103639 VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
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    K003684 PERCUSSIVENEB, MODEL PN-2001
    K001430 RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
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