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510(k) Data Aggregation

    K Number
    K232529
    Device Name
    Disposable Double Lumen Endobronchial Tube
    Manufacturer
    Shenzhen Insighters Medical Technology Co., Ltd.
    Date Cleared
    2024-05-13

    (266 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Product Code :

    CBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Double Lumen Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only.
    Device Description
    The Disposable Double Lumen Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung. The Disposable Double Lumen Endobronchial Tube is consisted with double lumen tube with the body including 2 cuffs (Bronchial Cuff and Tracheal Cuff). The tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, the bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. It is fitted with a stylet to enable shaping of the tube for navigation during intubation. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 8Fr or 10Fr with PVC and this device is packaged with two suction catheters. The Disposable Double Lumen Endobronchial Tube comes in three models, each model include two types: Ordinary Left Type, Ordinary Right Type, Visible Left Type B, Visible Right Type B, Visible Left Type, Visible Right Type. Each type will be available in six sizes: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr and 41 Fr. The device is composed of biologically safe materials. It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only. Environments of use: Hospital-OR and ICU.
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    K Number
    K232580
    Device Name
    Disposable Endobronchial Blocker Tube
    Manufacturer
    Shenzhen Insighters Medical Technology Co., Ltd.
    Date Cleared
    2023-12-14

    (111 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Product Code :

    CBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable 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 Blocked for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only. Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.
    Device Description
    The Disposable Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. It is composed of blocker catheter, cuff, three-way connector, tube connector, one-way valve (with a pilot balloon) and multifunctional adaptor. The blocker catheter has a flexible angled tip which can be easily placed into desired bronchus. It also contains a polyurethane cuff at its distal tip to create an effective seal within the inner bronchial wall and minimize potential trauma to the bronchus. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. This pilot balloon assembly facilitates inflation of the distal balloon and maintains inflation until it is released. The distance markings on the blocker catheter indicate how far the blocker has been advanced. The multi-functional adaptor can be used by connecting a blocker tube to various endotracheal tubes and anesthetic circuits. The Disposable Endobronchial Blocker Tube is available in three models: 5Fr, 7Fr and 9Fr. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.
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    K Number
    K222340
    Device Name
    Chartis Precision Catheter
    Manufacturer
    Pulmonx Corporation
    Date Cleared
    2022-12-01

    (120 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Product Code :

    CBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console is capital equipment that is reusable and displays the patient information.
    Device Description
    The Chartis Precision Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Precision Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Precision Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Precision Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Precision Catheter lumen during spontaneous respiration or air flow during mechanical ventilation. The Chartis Precision Catheter is designed for use in conjunction with the Chartis Console. The Chartis Console is a previously cleared device (under K180011) and the subject 510(k) is solely for the Chartis Precision Catheter.
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    K Number
    K201026
    Device Name
    sOLVe Tube
    Manufacturer
    HyTek Medical, Inc.
    Date Cleared
    2021-08-10

    (477 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Product Code :

    CBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sOLVe Tube™ is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
    Device Description
    The Simple One Lung Ventilation for Everyone (sOLVe) Tube is a single use dual lumen endobronchial tube (DLT) intended for lung isolation and for lung ventilation by healthcare professionals (HCP) in hospitals. The sOLVe Tube can function as both a left-sided and a rightsided DLT. The distal tip of the tube will fit in either the left or right mainstem bronchus. The sOLVe Tube is packaged and provided to the HCP as a kit. The kit includes the following components: 1. sOLVe Tube with pre-installed pliable aluminum 10Fr intubation stylet 2. Dual Bronchoscopy Swivel adapter with integrated safety clamp 3. Haider TubeGuard endotracheal tube holder/bite block with strap 4. Soft suction catheters 5. Two syringes (3 mL and 10 mL)
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    K Number
    K203749
    Device Name
    Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
    Manufacturer
    Ambu A/S
    Date Cleared
    2021-05-03

    (131 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Product Code :

    CBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intubation with Ambu VivaSight 2 DLT is indicated for pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation of one lung from the other, e.g. for thoracic surgery. Ambu VivaSight 2 DLT is a sterile, single-use, double-lumen endobronchial tube intended to be used for isolation of the left or right lung of a patient for one lung ventilation. The VivaSight 2 DLT system is intended to be used for verifying tube placement and repositioning. Intubation with VivaSight 2 DLT is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.
    Device Description
    Ambu VivaSight 2 DLT is a sterile, single-use, left-sided, double-lumen endobronchial tube with an embedded video camera and light source at the distal end of the tracheal lumen and integrated video cable with video connector. The embedded video camera is used for visualization during the intubation procedure and to verify the tube placement. The picture is shown on an Ambu displaying unit, which Ambu VivaSight 2 DLT is connected to via Ambu VivaSight 2 Adapter Cable. Ambu VivaSight 2 Adapter Cable is a non-sterile, single patient use accessory to Ambu VivaSight 2 DLT. Ambu VivaSight 2 DLT is connected to and powered by an Ambu displaying unit via Ambu VivaSight 2 Adapter Cable; the whole system is referred to as the VivaSight 2 DLT system. Ambu VivaSight 2 DLT is indicated for left or right lung isolation and use as a temporary artificial airway in adults requiring mechanical one-lung ventilation and is fitted with a stylet to enable shaping of the tube for navigation during intubation. A colorless tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, a blue bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. A flush line with flush exits next to the camera lens ensures possibility for cleaning of the camera lens. Ambu VivaSight 2 DLT can be connected to ventilation equipment via a Y-connector, which is included with the product. The Y-connector is sterile, single-use. The Y-connector caps enable lung deflation and use of accessories such as bronchoscopes and suction catheters in Ambu VivaSight 2 DLT. Furthermore, valves on the Y-connector enables opening and closing of the ventilation flow to each of the tracheal and bronchial lumens. The Y-connector airway tubes are colour coded to indicate tracheal and bronchial connection. Ambu VivaSight 2 DLT will be available in four sizes: 35 Fr, 37 Fr, 39 Fr, and 41 Fr.
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    K Number
    K200968
    Device Name
    ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
    Manufacturer
    INSUNG MEDICAL CO., LTD.
    Date Cleared
    2020-12-28

    (262 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Product Code :

    CBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
    Device Description
    ANKOR Endobronchial tube is consisted with double lumen tube with the body including 3 cuff (Bronchus Cuff, Trachea Cuff and ANKOR Cuff) / 2 cuff (Bronchus Cuff and Trachea Cuff), the stylet and elbow connector in order to separate connector for isolating and ventilating one lung during surgical procedures. The different point, between ABC Model and HBC Model, is whether ANKOR Cuff is consisted. ANKOR Cuff, which is a part of the ABC Model only, takes to check correct insertion of the catheter. When user is lack of the experience or is not confidence with operation, ABC Model is intended to use. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 10Fr or 12Fr with PVC (Listing Number: D422226) and this device is packaged with these suction catheter (Listing Number: D422226). The device is made of silicone as a main material and is available in 33Fr to 39Fr depending on the patients who is requiring one-lung isolation under OR and ICU including Non-MR Environment only.
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    K Number
    K181886
    Device Name
    VivaSight-DL System
    Manufacturer
    ETView Ltd.
    Date Cleared
    2018-11-14

    (124 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Product Code :

    CBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETView VivaSight-DL is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The VivaSight-DL System is indicated for verifying tube placement and repositioning.
    Device Description
    The ETView VivaSight-DLTM System functions as a standard endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen. The system provides a video image of the patient's bronchus, which is displayed on the monitor, for as long as the VivaSight-DL™ is inside the patient's bronchus. Visualization of the bronchus is used to verify placement and repositioning of the endobronchial tube during the intubation procedure or throughout surgery.
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    K Number
    K180253
    Device Name
    Sheridan Endobronchial Tubes
    Manufacturer
    Teleflex Medical
    Date Cleared
    2018-11-02

    (276 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Product Code :

    CBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SHERIDAN® Endobronchial Tube is intenced for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The SHERIDAN® Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
    Device Description
    The Sheridan Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.
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    K Number
    K160542
    Device Name
    5.0 Fr Arndt Endobronchial Blocker Set
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2016-08-02

    (158 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Product Code :

    CBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 5.0 Fr Arndt Endobronchial Blocker Set 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 5.0 Fr Arndt Endobronchial Blocker is indicated for pediatric populations, in children 1 year and older. The 9.0 Fr Arndt Endobronchial Blocker Set 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 9.0 Fr Arndt Endobronchial Blocker is indicated for adult use only.
    Device Description
    The 5.0 Fr Arndt Endobronchial Blocker Set and the 9.0 Fr Arndt Endobronchial Blocker Set are comprised of a blocker catheter with a silicone balloon near the distal end. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. A nylon guide loop at the distal end of the blocker catheter is wrapped around the tip of the bronchoscope and tightened, in order for the bronchoscope to assist in the precise placement of the blocker catheter. An Arndt Multiport Airway Adapter, a proximal straight connector, a suction adapter, and a syringe are also provided with each set.
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    K Number
    K152251
    Device Name
    Endobronchial Tube
    Manufacturer
    HENAN TUOREN MEDICAL DEVICE CO., LTD
    Date Cleared
    2016-06-10

    (305 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Product Code :

    CBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
    Device Description
    The Endobronchial Tube is made of Polyvinylchloride and is available in sizes 26fr to 41fr. They are designated as double lumen tube with 2 cuffs and separate 15mm connectors for isolating and ventilating one lung during surgical procedures. The tubes contain an x-ray opaque line that runs through the tube making them detectable by x-ray. Environments of use: Hospital-OR and ICU
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