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

    SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE

    K Number: K925615 · Decision Mar 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    33
    Applicant Total
    20
    Review Days
    140

    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
    SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE
    K Number
    K925615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5740
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    November 6, 1992
    Decision Date
    March 26, 1993
    Product Code
    CBI
    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
    CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

    Similar 510(k) Clearances

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

    Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Chartis Precision Catheter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Disposable Double Lumen Endobronchial Tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Disposable Endobronchial Blocker Tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Chartis Precision Catheter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    sOLVe Tube

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

    Other Clearances by Sorin Biomedica, Fiat, USA, Inc.

    K Number Device Name
    K931444 PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS
    K925661 STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
    K925369 BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
    K924354 STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
    K925541 STOCKERT 1/4 BUBBLE SENSOR
    K922933 SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
    K854963 S80 IMPLANTABLE CARDIAC PACING LEAD
    K852641 ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
    K851365 SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
    K841947 ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT
    Search all 20 clearances from Sorin Biomedica, Fiat, USA, Inc. →