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

    MODIFIED ENDOBRONCHIAL TUBE

    K Number: K902116 · Decision Aug 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    23
    Review Days
    85

    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
    MODIFIED ENDOBRONCHIAL TUBE
    K Number
    K902116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Concord/Portex
    Date Received
    May 10, 1990
    Decision Date
    August 3, 1990
    Product Code
    BTS
    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
    BTS Tube, Bronchial (W/Wo Connector)

    Similar 510(k) Clearances

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

    RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RUSCH ENDOBRONCHIAL TUBE SETS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOBRONCHIAL TWIN LUMEN TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BRONCHOSCOPY TUBE W/ULTRA LOCUFF

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BRONCHO-CATH

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

    Other Clearances by Concord/Portex

    K Number Device Name
    K923559 STERI-CATH MDI
    K930218 SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
    K924541 EPIDURAL MINIPACK
    K930286 DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS
    K923127 NEEDLE-PRO CARTRIDGE
    K923910 HEAT MOISTURE CONDENSER
    K922749 LOW PROFILE TRACHEOSTOMY TUBE
    K922445 VACU-PRO
    K915452 ANESTHESIA BREATHING CIRCUIT
    K911809 NEW-VENT
    Search all 23 clearances from Concord/Portex →