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Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.

Surgical Cricothyrotomy set for securing the airway in case of upper airway obstruction, respectively as "Ultima Ratio" if all other attempts to ventilate the patient failed. The set consists of scalpel, bougie, tube, extension tube with swivel connector, syringe and necktape.

The Retrograde Intubation Set is intended to assist in intubation during difficult or emergency airway access procedures in adult and pediatric patients. The 6 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 2.5 mm or larger. The 11 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 4 mm or larger. The 14 French catheter is recommended for use with a single-lumen 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 12 years of age.

The basic components included in the subject device, the Retrograde Intubation Set, are an introducer needle, catheter needle, syringe, hemostat, wire guide with wire guide inserter, intubation catheter, and Rapi-Fit® adapter. While the wire guide, intubation catheter, and Rapi-Fit® adapters are the subject of this De Novo request, this device is intended to be used with legally marketed needles, syringes, and hemostats. The needle and syringe are used to puncture the patient cricothyroid membrane and confirm needle placement in the patient airway. Then, a wire guide is inserted via the needle into a patient's trachea and exits via mouth or nose (i.e., retrograde). An intubating catheter is inserted orally or nasally over the wire guide into the trachea prior to intubation. This device offers optional Rapi-Fit adapters (attached to the intubating catheter) to facilitate supplemental oxygen delivery in adults prior to intubation with an endotracheal tube (ETT).

The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane. The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical is intended to establish emergency arrway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the surgical technique via the cricothyroid membrane. The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is intended to establish emergency arrway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing either the percutaneous entry (Seldinger) technique or the surgical technique via the cricothyroid membrane.

The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous, Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical, and the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set consist of an airway catheter, a loading dilator, a wire guide, a catheter needle, and an introducer needle. In addition to these components, standard preparation components, such as a syringe, scalpel, dilator forceps, gauze, drape, tracheostomy tape, and tracheal hook are included. The sets consist of any combination of components appropriate for either percutaneous or surgical placement of a cricothyrotomy tube, or both. The curved cricothyrotomy catheter is manufactured as a 22 French catheter with a length of 9 centimeters and an inner diameter of 5 millimeters. The loading dilators are either 11 centimeters or 12 centimeters long. The stainless steel wire guide has a 0.038-inch diameter and a length of 40 centimeters. The catheter needle is a two-part needle comprised of a small hubbed catheter sheath covering a hubbed needle. The sheath of the catheter needle is manufactured from fluorinated ethylene propylene tubing. The catheter needle is manufactured using an 18 gage cannula with a length of 7 centimeters. The introducer needle is also manufactured from 18 gage stainless steel and has a length of either 5 centimeters or 7 centimeters.

The Emergency Transtracheal Airway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed.

The Emergency Transtracheal Airway Catheter is composed of a catheter and needle. The catheter-needle assembly cannulates the trachea through the cricothyroid membrane in order to establish an airway. The catheter is designed as a 6.0 French catheters manufactured from reinforced fluorinated ethylene propylene (FEP) tubing fitted to a 15 gage stainless steel needle with a lancet bevel. The nominal length of the catheter measures 5.0 or 7.5 centimeters, depending upon device specification. The catheter French size is stamped on the proximal fitting of the catheter. The Luer hub on the proximal end of the catheter connects to an oxygen source. The needle is manufactured with a nickel plated brass hub. The lancet bevel of the needle extends from the catheter at the beel of the bevel. The needle and the hub are soldered with tin-silver alloy material. The catheter-needle assembly cannulates the trachea through the cricothyroid membrane in order to establish an airway. The needle is removed from the catheter after the catheter-needle assembly establishes an airway through the cricothyroid membrane, leaving the catheter in the trachea.

Rusch EasyCric Emergency Cricothyrotomy Set is indicated to provide emergency airway access when conventional ventilation by intubation or face mask cannot be performed.

The Rusch EasyCric Emergency Cricothyrotomy Set is a sterile, single use emergency cricothyroidotomy set available in size 5 mm. The device employs the Seldinger technique to provide an emergency artificial airway when attempts to intubate the trachea fail. Cricothyroidotomy provides faster access in emergency situations than surgical or percutaneous tracheostomy, which are time consuming procedures. The device gains access by cutting the link between the cricoid cartilage and the thyroid cartilage into the ligamentum conicum. It is available uncuffed. Components of the set include the EasyCric tube and insertion dilator, scalpel, puncture needle, syringe, guidewire, comport neckband and saline solution.

Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.

The new cricothyroidotomy kit is designed for introduction of an emergency 6mm cuffed airway tube through the cricothyroid membrane. The airway tube is provided pre-assembled onto a dilator with a Veress needle located in the centre. The kit employs two well-established and understood techniques: Firstly: The use of a Veress needle to provide visual indication of entry into a body cavity. (the trachea). (This can be confirmed by aspiration through the needle as with the predicate Cook Melker product ref. IFU in Attachment B(i)) The Veress needle is usually used for insufflation of the abdomen. It has a central sprung-loaded protective core to the needle that guards the cutting point and gives a visual indication via a "flag" at the hub end of the needle tip is passing through tissues. When the needle tip passes through into the abdominal cavity, or tractica, passure in ough assucer ------------------------------------------------------------------------------------------------------------------------------------------------------ Secondly: the use of a dilator/introducer to enlarge a stomal opening and place an airway tube within the traches. The pre-assembled needle/dilator/tube is inserted through the cricothyroid whill the tracether and the tube is then slid off the dilator fully into the trachea. This is the same principle employed by the Cook Melker Cricothyroidotomy sct. As well as the airway tube assembly, the kit provides the user with scalpel for skin incision, syringe for aspiration to confirm location of the needle in the trachea, sutures and neck-strap to secure the airway tube and a heat and moisture exchanger to reduce patient energy loss and protect the airway from blockage. These are all items that will be well understood by the user. Packaging comprises a rigid hinged blister pack for protection and a polythene/Tyvek welded pouch as the sterile barrier. pouch as ale sterilised and individually packed in a carton together with the directions for use.

Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

The Arndt Cricothyroid Catheter consists of a connector on the proximal end connected to tubing with an inner diameter. Through the catheter lumen is a dilator. The dilator provides a transition to a wire guide for insertion. The device is placed using the Seldinger technique. The catheter will be included in a set consisting of appropriately sized components.

Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

The Patil Cricothyroid Catheter consists of a connector on the proximal end connected to tubing with an inner diameter. Through the catheter lumen is a dilator. The dilator over a needle is used for insertion. The catheter will be included in a set consisting of appropriately sized components.

Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

The Melker Emergency Cricothyrotomy Catheter with a standard inner diameter of 3.5, 4, or 6 mm and a length of either 3.8, 4.2, 7.5 cm with a proximal fitting and a coaxial dilator tapered to a 0.038-inch wire guide.