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

    TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).

    K Number: K955461 · Decision Mar 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    3
    Review Days
    476

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    Basic Information

    Device Name
    TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
    K Number
    K955461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    VBM Medizintechnik GmbH
    Date Received
    November 29, 1995
    Decision Date
    March 19, 1997
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by VBM Medizintechnik GmbH

    K Number Device Name
    K200190 ScalpelCric
    K112783 MANUJET III