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The Impella CP Introducer is intended for introduction of pacing leads or catheters into the body.

The Impella CP Introducer is packaged as a sterile kit. which includes an introducer sheath (consisting of sheath with sideport tubing, stopcock and hemostasis valve assembly), and dilators, and a guidewire. It is identical to the commercially available predicate device, Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).

Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills

Endo Smart, Model ES-100 is a controller for micro motor and contra angle headpieces which is designed to assist dentists and dental surgeons perform standard endodontic procedures. It provides power to the hand-held micromotor and contra angle which holds the drill bit and/or file used in endodontic procedures. Endosmart is only intended to be used with motor hand piece (manufactured by Saeshin Precision Company; part name CUBE EP) and Contra angle headpiece (Manufactured by Saeshin Precision Company; part name ACL (B) - 42P) at 16:1 gear ratio.

MD-flex Heavy Body is used to record the shape of the patient's teeth and alveolar ridges.

MD-flex Heavy body is hydrophilic Polyvinylsiloxane Impression Material with thixotropic property, dimensional accuracy and excellent recovery from deformation. It complies with the requirements of ISO 4823:2000 Type 1 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge. The MD Flex Heavy Body package includes two dual-barrel 50 ml cartridges, and six mixing tips that allows for easy mixing of the base and catalyst. The device (cartridge) and accessories (mixing tip) are to be sold non-sterile. Testing demonstrates that MD-Flex has a shelf life 2 years from the manufacturing date. MD-Flex can be used to make a mold of a patient teeth and alveolar ridges. The mold can be used to generate Gypsum model within 30 minutes of removal of the mold from patient's mouth. The Gypsum model will be effectively reproduced without transformation due to an excellent reproducibility and volume stability of MD Flex.

REXTAR X is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray lmages using intraoral image receptors. It is intended for both adult and pediatric subjects.

The REXTAR X consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The Rextar model contains additional accessories. The REXTAR X is an extraoral source x-ray system with a DC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source a, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

REXTAR LCD is a portable X-ray systems to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

The REXTAR LCD consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The REXTAR LCD is an extraoral source x-ray system with a DC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source a, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

The IMPELLA 2.5 PLUS Catheter is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The IMPELLA 2.5 PLUS Catheter also provides pressure measurements which are useful in determining intravascular pressure.

The Impella 2.5 Plus is an update to the design of the IMPELLA 2.5, which was cleared by the FDA in 2008 (under K063723). The predicate device, the IMPELLA 2.5, and the Impella 2,5 Plus have identical designs and materials of construction. The only design modifications made to the IMPELLA 2.5 for the Impella 2.5 Plus are slight increases in the diameters of the inflow can ula impeller and pump housing (from 12 F to 14 F). As a result of this increase, the Impella 2.5 Plus has approximately 30% higher flow than the IMPELLA 2.5.

The IMPELLA Controller with Flow Control is an extracorporeal bypass control unit intended to be used to provide circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Controller with Flow Control is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (i.e. ambulance, helicopter, or fixed-wing aircraft) environments. The IMPELLA Controller with Flow Control also displays pressure measurement readings, which are useful in determining intravascular pressure.

The IMPELLA Controller with Flow Control is identical to the IMPELLA Controller in its physical characteristics. The only difference is that an additional operating mode. Flow Control Mode, has been implemented via a software modification. Both the IMPELLA Controller and the IMPELLA Controller with Flow Control are identical microprocessor-based pump motor drivers incorporating an infusion system. They both are intended to be used by trained healthcare professionals in hospital and medical transport environments.

The Model 300157 CPAP System is a single patient reusable device. The Model 300157 CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with Obstructive Sleep Apnea.

The CPAP System provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. When interfaced with a CPAP Mask or CPAP Patient Interface the CPAP System provides a constant pressure of 4 to 20 cmHzO above the ambient atmospheric pressure to patient's nasal airway. This constant pressure, when set to a therapeutic level as prescribed by a physician, supports retaining an open airway during sleep. The CPAP System has primary components: 1) CPAP main unit, 2) Removable headgear, 3) External power supply/optional mobile power adaptor, and 4) Patient Interface.

The IMPELLA Controller is an extracorporeal bypass control unit intended to be used to provide circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Controller is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (i.e. ambulance, helicopter, or fixed-wing aircraft) environments. The IMPELLA Controller also displays pressure measurement readings, which are useful in determining intravascular pressure.

The IMPELLA Controller is a microprocessor-based pump motor driver and purge system. It is designed to operate on AC current (110-240 VAC, 47-63 Hz) or on an internal, rechargeable battery. The IMPELLA Controller generates the signals required to power the drive motor of one of ABIOMED's IMPELLA Percutaneous Support Catheters (the IMPELLA RECOVER LP 2.5 (cleared under K063723), the IMPELLA 5.0 LP and the IMPELLA 5.0 LD (cleared under K083111). The IMPELLA Controller also serves to deliver an infusate of the catheter's drive motor, and to provide useful information regarding the catheter's performance. It is intended to be used by trained healthcare professionals in hospital and medical transport environments. It is lightweight, portable and has an accompanying cart for ease of transport within the hospital.