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510(k) Data Aggregation

    K Number
    K162729
    Device Name
    Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2017-08-11

    (316 days)

    Product Code
    BSR, BTR
    Regulation Number
    868.5790
    Why did this record match?
    Product Code :

    BSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook Airway Exchange Catheter is intended for endotracheal tube exchange in adult and pediatric patients. The 8 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 3 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 8 French catheter is recommended for patients older than 1 month of age. The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age. The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age. The 19 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 7 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 19 French catheter is recommended for patients older than 12 years of age. The Cook Airway Exchange Catheter - Extra-Firm with Soft Tip is intended for endotracheal tube exchange in adult and pediatric patients. The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age. The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age. The Arndt Airway Exchange Catheter Set is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients. The product may be used for emergency, urgent, and elective airway management. The 14 French catheter is recommended for placement of an endotracheal tube or a supraglottic airway device with an inner diameter of 5 mm or larger. When used for high-pressure oxygenation with a Luer lock connector, the 14 French catheter is recommended for patients older than 12 years of age. The Aintree Intubation Catheter is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients. The 19 French catheter is recommended for use with a supraglottic airway device and placement of a single-lumen endotracheal tube with an inner diameter of 7 mm or larger. When used for high-pressure oxygenation with a Luer lock connector, the 19 French catheter is recommended for patients older than 12 years of age.
    Device Description
    The Respiratory Management Sets are a family of airway management products, designed for establishing, re-establishing, or maintaining an airway. The catheters may be manufactured from polyurethane or polyethylene. They are single lumen catheters and are designed with a blunt or tapered distal tip. Incremental markings on the catheter shafts facilitate the accurate placement of the catheters into the airway. The subject device catheters have sideports at the distal end and the subject devices are provided with two Rapi-Fit adapters for ventilation when oxygen requirement is high and the supraglottic airway device or endotracheal tube is not in the trachea of the patients. The Aintree Intubation Catheter is comprised of an intubation catheter, two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector), and a double swivel connector. The intubation catheter is made of polyurethane and is 19 Fr in diameter and 56 cm long. The distal end of the intubation catheter is open and designed with a straight and tapered tip, with two sideports aligned opposite to each other. The Arndt Airway Exchange Catheter Set is comprised of an exchange catheter, a wire guide, two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector), and a double swivel connector. The catheter is made of polyurethane and is 14 Fr in diameter and 70 cm long. The distal end of the exchange catheter is open and designed with a straight and tapered tip, with six sideports spiraled along the distal tip. The Cook Airway Exchange Catheter is comprised of an exchange catheter and two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector). The 8, 11, and 14 Fr catheters are made of polyurethane, while the 19 Fr catheter is made of polyethylene. The 8 Fr catheter is 45 cm long, while the 11, 14, and 19 Fr catheters are 83 cm long. The distal ends of the exchange catheters are open and designed with a straight and tapered tip. The 8 Fr, 14 Fr, and 19 Fr catheters have two sideports aligned opposite to each other, while the 11 Fr catheter has six sideports spiraled along the distal end. The Cook Airway Exchange Catheter – Extra-Firm with Soft Tip are comprised of an exchange catheter and two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector). The exchange catheter is made of polyurethane intermittent extrusion tubing, with a stiff shaft and a softer distal 7 cm of the catheter is made of a softer and more flexible polyurethane). The catheter is available in diameters of 11 or 14 Fr, and a length or 100 cm. The distal ends of the exchange catheters are open and designed with a straight and blunt tip. The 11 Fr catheter has six sideports spiraled along the distal end, while the 14 Fr catheter has two sideports aligned opposite to each other.
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    K Number
    K962361
    Device Name
    TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
    Manufacturer
    LAERDAL MEDICAL CORP.
    Date Cleared
    1996-09-05

    (78 days)

    Product Code
    BSR
    Regulation Number
    868.5790
    Why did this record match?
    Product Code :

    BSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954771
    Device Name
    TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
    Manufacturer
    LAERDAL MEDICAL CORP.
    Date Cleared
    1996-05-09

    (205 days)

    Product Code
    BSR
    Regulation Number
    868.5790
    Why did this record match?
    Product Code :

    BSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trachlight is designed to facilitate the placement of endotracheal tubes of various sizes and lengths for both orotracheal and nasotracheal intubations.
    Device Description
    The Trachlight includes a wand with an incandescent light bulb at its tip that is placed inside the endotracheal tube prior to intubation, with the light bulb positioned at the end of the endotracheal tube. Light from the light bulb helps provide a guide for the clinician during the intubation process, and light emanating from the light bulb can be seen through the patient's tissue when the end of the endotracheal tube is properly positioned in the patient's trachea. The Trachlight consists of a reusable handle that contains the batteries and electronic circuits to apply power to the light bulb; a sterile, flexible wand that contains the light bulb at the tip; and a stylet that slides into the wand and acts as a stiffening member when needed.
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    K Number
    K943104
    Device Name
    MOLLOY INTUBATING STYLETTE
    Manufacturer
    MOLLOY CORP.
    Date Cleared
    1996-04-18

    (659 days)

    Product Code
    BSR
    Regulation Number
    868.5790
    Why did this record match?
    Product Code :

    BSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955238
    Device Name
    RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
    Manufacturer
    RUSCH INTL.
    Date Cleared
    1996-02-06

    (84 days)

    Product Code
    BSR
    Regulation Number
    868.5790
    Why did this record match?
    Product Code :

    BSR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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