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The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

The JETi™ Hydrodynamic Thrombectomy System (JETi HTS) is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi™ Catheter, JETi™ Pump Set, JETi™ Saline Drive Unit (SDU), JETi™ Accessory Cart, JETi™ Suction Tubing, and JETi™ Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.

The JETiTM Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and thrombus from the peripheral vasculature and to sub-selectively infuse/deliver diagnostics with or without vessel occlusion.

The JETiTM Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETiTM Catheter, JETiTM Pump Set, JETiTM Saline Drive Unit (SDU), JETiTM Accessory Cart, JETiTM Suction Tubing, and JETiTM Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated. The JETi Catheter has two (2) lumens. The primary lumen (largest) is a conduit for thrombus aspiration. A secondary lumen, placed within the primary lumen, delivers saline through an orifice to break up and dilute the aspirated thrombus and facilitates rapid movement of the aspirate towards the vacuum. One (1) radiopaque (RO) marker band is located stiff proximal section which transitions to a more flexible distal section with a round, soft tip. A filter is incorporated into the catheter connector to ensure that no debris or foreign material is injected into the patient vasculature. The JETi Catheter is available in two sizes: 6 French size (6F) and 8 French size (8F). The JETi Pump Set is intended to deliver a high pressure sterile saline stream to the JETi Catheter. The pressure for the saline stream is created through the cassette's piston assembly, which snaps into the SDU. The JETi Saline Drive Unit (SDU) is a non-sterile reusable, (multiple patient, multiple use) device that incorporates the saline pumping components and the vacuum pump within a single enclosure. The fork drive of the SDU is designed to run the JETi Pump Set piston assembly to deliver a stream of saline to the JETi Catheter when activated by the handheld switch if the vacuum is present. In conjunction with the JETi Pump Set, the SDU can sub selectively infuse / deliver diagnostics or therapeutic fluids when utilizing the optional HYPER PULSETM Fluid Delivery feature. The JETi Suction Tubing is a sterile single use device that incorporates the pressure monitoring sensor and valve into a single enclosure, that is in-line with the aspiration lumen, for the handheld switch. When the handheld switch is activated, within the aspiration lumen, the diluted thrombus and saline is then drawn back through the primary lumen of the JETi Catheter and deposited into the vacuum source (JETi Non-sterile Canister Set) via the JETi Suction Tubing. When the handheld switch is de-activated, a valve closes, stopping the flow of thrombus, and a relief valve inside the SDU briefly opens and closes to reduce foaming at the vacuum source (JETi Non-sterile Canister Set). The SDU contains a microprocessor-controller circuit board and firmware that monitors various functions of the motor and vacuum to ensure that the device is functioning as expected. A Liquid Crystal Display (LCD) screen on the front panel of the SDU indicates to the user the status of the system. Several safety features are incorporated into the firmware to ensure proper functionality. The SDU is supported by a mobile, height adjustable cart with an integrated IV pole. Energy is provided by a 24-volt external power supply, which is connected to the main supply. The external power supply is provided with the SDU and is part of the system

The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring.

The MicroAire® Power Assisted Liposuction (PAL®) Infiltration System is a medical device intended for aesthetic body contouring. The PAL Infiltration System is a stand-alone peristaltic Infiltration Pump, with the ability to control ON/OFF function to the PAL Handpiece (sold separately), the Infiltration Pump, or a Foot Switch (INF-FOOT-1) depending on the doctor's preference. The PAL® Infiltration System is comprised of the following components that are subject to this 510K: - INF-PUMP PAL Infiltration Pump - Accessories - o PAL-INF-1600 Infiltration Tubing - o PAL-INF-XXXXX Single-Use Infiltration Cannulas - o PAL-INF-RXXXXX Multi-Use Infiltration Cannula - o INF-CBL-5020, Infiltration Pump to 5020 Console Connector Cable - o INF-FOOT-1, Infiltration Foot Switch

The A8, A9 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A8, A9 is intended for use by licensed clinicians in the administration of general anesthesia, for patients requiring anesthesia within a health care facility, and can be used in adult, pediatric and neonate populations. High Flow Nasal Cannula (HFNC) is indicated for delivery of nasal high flow oxygen to spontaneously breathing adult patients. It can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms. It is not intended for apneic ventilation. HFNC is indicated for use in adults only.

The A8, A9 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A8, A9 Anesthesia System incorporates O2, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Halothane, and Sevoflurane). The A8, A9 Anesthesia System is a modified version the previously cleared Mindray A7 Anesthesia System cleared in K171292.

The A7 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric (including neonate, infant, child and adolescent) populations.

The A7 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A7 incorporates 02, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane).

AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

AnapnoGuard 100 Respiratory Guard System is comprised of the following three main components: The AnapnoGuard endotracheal tube (ETT) with inflatable cuff (FDA cleared under K093126). The AnapnoGuard 100 Respiratory Guard System interconnection harness of tubes, connecting the ETT to the AnapnoGuard 100 control unit The AnapnoGuard 100 Respiratory Guard System control unit which consists of the following main modules: Host computer (PC) Microcontroller (MCU) Suction module (regulator and flow potency meter): including . a set of valves and pipes controlling the secretions suction/evacuation from above the ETT cuff. Rinsing module: Pumps saline to rinse the Suction and Vent/ ● CO2 lumens. CO2 analyzer module: including CO2 analyzer assembly, ● pump, valve and flow filter which sucks air from the subglottic space above the ETT cuff into the CO2 analyzer. . Cuff pressure module: includes two pressure gauges which monitor cuff pressure, a miniature air pump and two valves. Pneumatic module: valves, pipes and filters . Connectors panel for connecting the interconnection harness . (ETT), vacuum, trap bottle, rinsing fluid and filters. Operation buttons panel and navigation wheel . I/O communication panel . Display monitor . AnapnoGuard 100 Respiratory Guard System, including its three components monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.

The A7 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.

The A7 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A7 incorporates O2, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane). The A7 consists of a main unit (includes an anesthetic ventilator and flow meter monitor assembly) and a detachable breathing system.

The A7 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.

The A7 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A7 incorporates 02, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane). The A7 consists of a main unit (includes an anesthetic ventilator and flow meter monitor assembly) and a detachable breathing system.

The Naväge Nose Cleaner is intended to help relieve nasal and/or sinus congestion and stuffiness by washing and moisturizing the nasal cavity with a pressure-controlled stream of irrigant rinse.

The Naväge Nose Cleaner ("Naväge") is a powered nasal irrigator intended for OTC use to wash and moisturize the nasal cavity. There are many nasal irrigation devices in commercial distribution in the US, and Naväge is substantially identical to those devices in terms of intended use and indications for use. It is similar in terms of mechanical functionality with the single exception that in addition to using positive pressure, Naväge simultaneously uses negative pressure (suction). That is, the device uses a combination of positive pressure (gravity) to introduce irrigant rinse into the nasal cavity, and negative pressure (powered suction) to aspirate the rinse out of the nasal cavity. The simultaneous use of positive and negative pressure makes it possible for the device to be self-contained so that after washing through the nasal cavity, the irrigant rinse can flow into a removable collection tank attached to the device. This provides an improved nasal irrigation experience resulting from functional simplicity, superior ergonomics, and less mess than currently available devices.

The Epix® Suction Irrigation System is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, and laparoscopic and open urologic surgery. This device delivers sterile irrigant solution and serves as a conduit for suction.

The Epix Irrigation Pump (model C7000) is reusable and operates outside of the sterile field. The Epix Suction Irrigation Tubing Set (model C7100) is a sterile, single use device, used in conjunction with the Epix Irrigation Pump and the house vacuum to deliver sterile irrigation fluids and to evacuate blood, tissue debris, and smoke from the surgical site.