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

    SIMS BLUE LINE ENDOBRONCHIAL TUBE

    K Number: K953483 · Decision Oct 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    33
    Applicant Total
    22
    Review Days
    91

    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
    SIMS BLUE LINE ENDOBRONCHIAL TUBE
    K Number
    K953483
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5740
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Industries Medical Systems, Inc.
    Date Received
    July 25, 1995
    Decision Date
    October 24, 1995
    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 Smiths Industries Medical Systems, Inc.

    K Number Device Name
    K972385 FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
    K965017 REGIONAL ANESTHESIA TRAYS
    K962175 PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
    K962931 SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
    K963570 SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
    K960429 PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
    K953485 SIMS CPAP SYSTEM
    K932946 WALLACE IV CANNULA
    K932947 WALLACE Y-CAN
    K952516 PRO-VENT, LINE DRAW, PULSATOR
    Search all 22 clearances from Smiths Industries Medical Systems, Inc. →