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

    BIVONA TRACHEOSTOMA VALVE II

    K Number: K852272 · Decision Jul 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    50
    Review Days
    41

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    Basic Information

    Device Name
    BIVONA TRACHEOSTOMA VALVE II
    K Number
    K852272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bivona Medical Technologies
    Date Received
    May 28, 1985
    Decision Date
    July 8, 1985
    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 Bivona Medical Technologies

    K Number Device Name
    K952700 SUPERSLICK
    K942025 BURGET NASAL STENT
    K944178 BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
    K935053 BIVONA NASAL TURBINATE STENT
    K933398 BIVONA ILLUMINATED ENDOTRACHEAL TUBE
    K931749 BIVONA(R) ICU ENDOTRACHEAL TUBE
    K922665 BIVONA HYPERFLEX TRACHEOSTOMY TUBE
    K923878 BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
    K920604 BIVONA TRACHEAL T-TUBE STENT
    K915761 BIVONA-COLORADO VOICE PROSTHESIS
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