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

    TRACHEOSTOMY TUBES, SHORT AND LONG TERM

    K Number: K791044 · Decision Jun 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    69
    Review Days
    8

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TRACHEOSTOMY TUBES, SHORT AND LONG TERM
    K Number
    K791044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    June 5, 1979
    Decision Date
    June 13, 1979
    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)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BTO), ordered by most recent decision date.

    5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Pilling Tracheostomy Tubes

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Extracorporeal Medical Specialities, Inc.

    K Number Device Name
    K843955 EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
    K840532 HEMOPERFUSION SYSTEM TP-400
    K840262 HANCOCK PERICARDIAL PATCH
    K840146 EXP* 700 PARALLEL PLATE DIALYZER
    K840057 EXP* 500 PARALLEL PLATE DIALYZER
    K831423 THERAPEUTIC EXCHANGE SYSTEM
    K832547 ULTRAFILTRATION CONTROLLER
    K833477 INTERSEPT 40 MICRON FILTER
    K833476 INTERSEPT 40 MICRON FILTER W/TUBING
    K831424 THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
    Search all 69 clearances from Extracorporeal Medical Specialities, Inc. →