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QUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. QUANTIEN Measurement System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

QUANTIEN Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire (K113584, K080813, K062769) and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR) and data from ECG. Information on screen can also be transferred to an external hemodynamic recording system or to an external video monitor. Recorded procedures can be viewed on a PC for review and analysis with application specific viewing software installed, such as RadiView™ software. Additional functions allow for import of a patient work list from the hospital DICOM system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick.

RadiAnalyzer® Xpress is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters with Pressure Wire®. RadiAnalyzer® Xpress is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological and blood flow parameters based on the output from one or more electrodes, transducers or measuring devices.

RadiAnalyzer® Xpress is a diagnostic computer designed to compute, record and display information from Pressure Wire® and other external transducers. The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RadiAnalyzer® Printer and/or PC with external viewing software installed, such as RadiView® or PhysioMon™. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR). RadiAnalyzer® Xpress can be upgraded with additional software, such as Thermo Option software to enable assessments of invasive temperature, Coronary Flow Reserve (CFR) or other physiological parameters such as first time derivative of pressure (dP/dt). RadiAnalyzer® Xpress comes with one remote control, two monitor cables, one adapter cable, and one mains cable (standard configuration).

PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessel.

PressureWire® is a .014" guidewire with an integrated pressure and temperature sensor. together with a detachable cable or transmitter/receiver for connection to a diagnostic computer or a cathlab hemodynamic recording system.

FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm .

This combination of FemoStop®Femoral Compression System consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer, a belt and a hemostatic dressing and is called FemoStop®Gold Femoral Compression System. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The pressure of the dome is controlled by the integrated pump and the manometer. The arch and belt provide counter pressure for the dome. The sterile hemostatic dressing is placed on the skin incision site as a bacterial barrier and for topical control of bleeding,

PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

Pressure Wire® is a .014" guidewire with an integrated pressure and temperature sensor, together with a detachable cable for connection to a diagnostic computer.

RadiAnalyzer® is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. RadiAnalyzer® is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

RADIAnalyzer® is a diagnostic computer designed to compute, record and display information, based on the input from PressureWire® Sensor and an Aortic Pressure Transducer (AO). The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RADIAnalyzer® Printer and/or PC with external vicwing software installed such as RADIView® Software. Data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR) and temperature.

TopSeal™ Hemostatic Dressing is indicated for control of minor bleeding from wounds and lacerations or minor bleeding from skin incisions or punctures following percutaneous medical procedures.

TopSeal™ Hemostatic Dressing is a sterile dressing impregnated with the hemostatic agent m.docTM (calcium/sodium salt of micro-dispersed oxidized cellulose). The active hemostatic agent promotes the topical control of bleeding. The dressing comes as a pad which is impermeable to water and acts as a bacterial barrier.

The PressureWire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

The PressureWire™ Sensor is a 0.014" diameter, 183 or 300 cm long guidewire with a pressure sensor mounted three cm from the distal end and a detachable cable for connection to a programmable diagnostic computer manufactured by the submitter.

FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm

The FemoStop®Femoral Compression System consists of an arch with a sterile pneumatic pressure dome attached to an arch, a belt, and a reusable pump with manometer. With this application a sterile hemostatic dressing, HD, is added to the system. The dressing has an active agent made of calcium/sodium salt of micro dispersed oxidized cellulose for topical control of bleeding.

RADIAnalyzer™ is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. RADIAnalyzer™ is intended for use in catheterization and related cardiovascular specially laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices.

RADIAnalyzer™ is a diagnostic computer designed to compute, record and display information, based on the input from PressureWire™ Sensor and other External Pressure Transducer. The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RADIAnalyzer™ Printer and/or PC with RADIView™ installed. Data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR) and temperature.