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

    RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED

    K Number: K021764 · Decision Jul 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    43
    Review Days
    55

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    Basic Information

    Device Name
    RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
    K Number
    K021764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rusch Intl.
    Date Received
    May 29, 2002
    Decision Date
    July 23, 2002
    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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    BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

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    Other Clearances by Rusch Intl.

    K Number Device Name
    K033023 INTERMITTENT URETHRAL CATHETERS
    K030559 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
    K023666 RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
    K023918 RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
    K023964 RUSCH MICROLARYNGEAL TUBE
    K021540 RUSCH EDGAR TUBE
    K020714 RUSCH FLONEIL; FLOCATH INTROGEL
    K010798 RUSCH CANTOR TUBE
    K010797 RUSCH MILLER-ABBOTT TUBE
    K013872 RUSCH MEMORY BAG
    Search all 43 clearances from Rusch Intl. →