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510(k) Data Aggregation

    K Number
    K251499
    Device Name
    Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
    Manufacturer
    William Cook Europe Aps
    Date Cleared
    2025-06-11

    (27 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    BTR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Frova Intubating Introducer is indicated to facilitate endotracheal intubation in patients where visualization of the glottis is inadequate e.g., as in grade II and III Cormack-Lehane views. This indication applies for introduction of a single lumen endotracheal tube with an inner diameter of 6 mm or larger. The Frova Intubating Introducer is also designed for transient oxygenation or jet ventilation in combination with 14 Fr compatible Rapi-Fit Adapters (15 mm and female Luer lock connector). The Rapi-Fit Adapters should only be used when oxygen requirements are high.
    Device Description
    The Frova Intubating Introducer is a 14 French, 70 cm long radiopaque introducer with centimeter markings and a blunt, curved tip that can be passed into the trachea. The introducer has a through lumen design with two distal sideports to ensure adequate airflow. The Frova Intubating Introducer can be supplied with a stiffening stylet and two Rapi-Fit® Adapters for connection to an oxygen source. The Frova Intubating Introducer is designed to facilitate airway intubation and allows for transient oxygenation and/or jet ventilation during the initial intubation. The Rapi-Fit Adapter with a 15 mm connector is intended for use with a 14 Fr Frova Intubating Introducer for connection to an oxygen source to facilitate transient oxygenation during intubation. The Rapi-Fit Adapter with a female Luer lock connector is intended for use with a 14 Fr Frova Intubating Introducer for connection to an oxygen source to facilitate transient oxygenation or jet ventilation during intubation. The stiffening stylet is intended to add rigidity to the proximal and middle sections of the introducer, while the distal portion remains flexible. The different configurations of the Frova Intubating Introducer are supplied sterile and are for single use only.
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    K Number
    K250243
    Device Name
    ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
    Manufacturer
    Flexicare Medical Limited
    Date Cleared
    2025-05-20

    (113 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    BTR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProVu Endotracheal Tube with Video Stylet is intended for intubation procedures. The ProVu Endotracheal Tube with Video Stylet is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The ProVu Endotracheal Tube with Video Stylet is indicated for viewing during non-difficult and difficult intubation procedures and for verifying endotracheal tube placement.
    Device Description
    The ProVu Video Stylet with Reinforced ET Tube is a sterile, single-use, video-enabled stylet and ETT intubation system with malleable and directional control intended to assist with oral and nasal intubations and designed for use in adults in a hospital environment. The device comprises of two main components: - The ProVu Reinforced Endotracheal tube - The ProVu Video Stylet (with a removable malleable rod)
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    K Number
    K242495
    Device Name
    LMA Fastrach ETT SU
    Manufacturer
    Teleflex Medical
    Date Cleared
    2025-04-29

    (250 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    BTR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LMA® Fastrach™ ETT Single Use is indicated for tracheal intubation through the LMA® Fastrach™. The Stabiliser Rod is indicated for use during removal of the LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the LMA® Fastrach ™ ETT Single Use in place.
    Device Description
    The LMA® Fastrach™ ETT Single Use has been developed specifically for use with the LMA® Fastrach™. It is a straight, cuffed, wire-reinforced tube with a Murphy Eye and a standard 15mm connector. The LMA® Fastrach™ ETT Single Use has a pilot balloon with a luer check valve and a unique, soft, moulded tip for atraumatic passage through the vocal cords. As a reference during intubation, the LMA® Fastrach™ ETT Single Use has depth markers to indicate the distance to the distal tip of the LMA™ airway. The LMA® Fastrach™ ETT Single Use is radiopaque along its full length and its tip is made out of a radio opaque material to enhance its visibility in x-rays. Accessory device: The Stabiliser Rod Single Use is an accessory and it is indicated for use during removal of the reusable LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the Endotracheal Tube (ETT) in place.
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    K Number
    K241451
    Device Name
    Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)
    Manufacturer
    Teleflex Incorporated
    Date Cleared
    2025-02-11

    (265 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    BTR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotrached to be used on all patients requiring ventilation, pediatric and adult. Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.
    Device Description
    An endotracheal tube is a device that is inserted into the trachea via the nose or the mouth to establish a patent airway to allow ventilation. The proposed Teleflex Medical Rusch Endotracheal Tubes are sterile, single use devices that are made non made with DEHP. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the Safety Clear tracheal tube, while the Reinforced tube contains an embedded stainless-steel spiral that allows for X-ray visualization. Each tracheal tube is supplied with an appropriately sized 15mm connector.
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    K Number
    K233341
    Device Name
    Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
    Manufacturer
    Covidien LLC
    Date Cleared
    2024-05-20

    (234 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    BTR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP is intended for oral or nasal intubation of the trachea. The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is intended for use in oral or nasal intubation of the trachea for anesthesia and is indicated for airway management.
    Device Description
    The subject device is an oral/nasal endotracheal tube intermediate cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) high pressure, low volume cuff with two different cuff shapes. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.
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    K Number
    K223130
    Device Name
    Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
    Manufacturer
    Covidien
    Date Cleared
    2023-08-30

    (331 days)

    Product Code
    BTR, ANE
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    BTR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shiley™ pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non DEHP is intended for use in facilitating oral or nasal intubation of the trachea.
    Device Description
    The subject device is pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) low pressure taper-shaped cuff (TaperGuard™) to provide air and fluid seal. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.
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    K Number
    K211543
    Device Name
    Wei Nasal Jet Tube
    Manufacturer
    Well Lead Medical Co., LTD.
    Date Cleared
    2022-07-21

    (428 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    BTR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WEI nasal jet tube is indication for airway management, inserted through nasal cavity. During and after insertion, the Jet Tube can supply jet ventilation intermittently. When the Jet tube is not in use, the main tube serves as the main oxygen supply channel, and oxygen is supplied through main tube. The PetCO2 Monitor tube can connect to CO2 monitoring machine to monitor CO2 status.
    Device Description
    Wei Nasal Jet Tube is a sterile, single-use nasopharyngeal airway management, monitor PetCO2 and mechanical ventilation. Wei Nasal Jet Tube inserted into a patient's pharynx through the nose, it provides active, pulsatile and powerful supraglottic jet oxygenation and ventilation (SJOV) via a jet channel built into the wall of its distal end. It can be used to monitor PetCO2 via another channel built into the wall and open to the middle lumen of the tube. Wei Nasal Jet Tube can also augment oxygen supplies for patients with respiratory suppression or apnea during difficult airway managements.
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    K Number
    K213028
    Device Name
    Tenax Laser Resistant Endotracheal Tube
    Manufacturer
    Bryan Medical , Inc.
    Date Cleared
    2021-10-21

    (30 days)

    Product Code
    BTR, BSK
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    BTR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns), KTP (532 nm) or Blue Laser (445mm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway.
    Device Description
    The Tenax® Laser Resistant Endotracheal Tube is an endotracheal tube with two inflatable cuffs. It is indicated for use in surgical procedures where intubation is required in the presence of KTP, 445nm Blue Laser, or CO2 lasers. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations. There are no associated device accessories.
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    K Number
    K200761
    Device Name
    Tenax Laser Resistant Endotracheal Tube
    Manufacturer
    Bryan Medical, Inc.
    Date Cleared
    2020-11-25

    (246 days)

    Product Code
    BTR, BSK
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    BTR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway.
    Device Description
    The Tenax® Laser Resistant Endotracheal Tube is an endotracheal tube with two inflatable cuffs. It is indicated for use in surgical procedures where intubation is required in the presence of KTP or CO2 lasers. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations. There are no associated device accessories.
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    K Number
    K192120
    Device Name
    Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm
    Manufacturer
    Venner Medical (Singapore) Pte Ltd
    Date Cleared
    2020-02-14

    (192 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Product Code :

    BTR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venner Pneux ™ ETT (Endotracheal Tube) is intended to be used for patients undergoing tracheal intubation during routine anesthesia or over extended periods (not more than 30 days) and for the evacuation or drainage of secretion from the subglottic space.
    Device Description
    The Venner PneuX ETT (Endotracheal Tube) is a disposable, sterile, single-patient, single-use device. It is a straight, flexible cuffed (low volume, low pressure) Nitinol wire-reinforced tracheal tube with a Murphy Eye. When a patient is intubated with a Venner PneuX ETT and inflated by standard techniques, it can be attached to the Venner PneuX TSM™M via the Venner PneuX™ Extension Tube, to monitor, maintain and regulate cuff pressure. The Venner Pneux TSM, a cuff pressure controller, was cleared for marketing via 510(k) application K110631 and the Venner PneuX Extension Tube is a class I, 510(k) exempt device. The Venner PneuX ETT is available in four sizes (inner diameters: 6.0, 7.0, 8.0 and 9.0 mm) and is MRI compatible. Depth markings indicate the distal tip of the tube and a printed black line provides a means to orient the tube. The device provides access to subglottic space by having three additional lumens running along the airway lumen. The three lumens are integrated into the tube wall ending just above the proximal end of the cuff for ease of suction. Connected to the suction tube and subglottic connector, it allows intermittent suctioning of secretions from the subglottic space, and irrigation. A winged tube holder allows for securement with openings on each end for a head/neck strap to pass through. An integrated bite block with fixation block provides a protective covering and secures the position of the tube to preventunintended movement duringuse. A standard connector (15mm)for universal attachment to a ventilator or anesthesia equipment is present, as well as an inflation line to connect the cuff for inflation and deflation. A pilot balloon connects the cuff to provide an indication of the pressure within the cuff and the pilot valve opens to allow free flow of air to the cuff for inflation when a Luer lock syringe is engaged. When the syringe is removed, the valve closes to prevent leakage of air and ensures the cuff is inflated.
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