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510(k) Data Aggregation

    K Number
    K251950

    Validate with FDA (Live)

    Device Name
    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)
    Manufacturer
    Hangzhou Tappa Medical Technology Co., Ltd.
    Date Cleared
    2026-03-20

    (268 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    0 - 17
    Reference & Predicate Devices
    K160542,K021920,K093888
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Endobronchial Blocker Tube is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5Fr Endobronchial Blocker Tube is indicated for pediatric populations, in children with minimum 10 Kg of weight. All other sizes are for adult use only.

    Device Description

    The Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only. Widely used in combination with various endotracheal tubes, it doesn't require re-intubation at the conclusion of surgery as with a double-lumen endotracheal tube. Doctor can easily move the blocker from one side to the other and place the cuff on the target airway accurately by rotating the outside tube. The angled tip lets the blocker easily enter any bronchus and adjust position. Aspiration of secreted material can be done via the suction port. The auto inflator can be operated with one hand to the cuff.

    AI/ML Overview

    N/A

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