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VT75-E1 Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m². VT75-E2 Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use. Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².

The Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethylpentene (PMP). In this chamber, carbon dioxide moves from the blood to the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating.

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use. Device is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age). Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use. Devices is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).

Quantum Perfusion Blood Oxygenator devices, VT75-C1U and VT75-C2U, consist of an oxygenator with an integrated arterial filter. The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surqical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.

The Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either: (i) Full of partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava. Devices are intended for adult patients.

The Quantum Perfusion Centrifugal Blood Pump with Integrated Sensors is a standalone single use device intended to pump blood into the extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours. The device is equipped with two sensors integrated in the blood inlet and outlet connectors. The device is non-toxic, non pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.

The Quantum Perfusion Centrifugal Blood Pump CP20, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age) The Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either: Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on (i) the heart or great vessels; or Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava. Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)

Quantum Perfusion Centrifugal Blood Pump CP20 and Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors are standalone single use device intended to pump blood into the extracorporeal circulation circuit and to monitor pressure for periods lasting less than 6 hours. Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors is equipped with two sensors integrated in the blood inlet and outlet connectors. Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.

Quantum Perfusion Dual Lumen Cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

All medical devices pertaining to Quantum Perfusion Dual Lumen Cannula product family are single use devices intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. Devices are characterized by two coaxial catheters and are designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal. Devices exploit a single site insertion which reduces the invasiveness of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter and returned through the lumen of the inner catheter. Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood. Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the devices' surfaces in contact with blood are coated with a phosphorylcholinebased biocompatible material.

Quantum SuperPAC Tubing set is a set of tubing intended for use during cardiopulmonary bypass for a duration up to 6 hours. Quantum SuperPAC Cardioplegia Set is a tubing set used for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.

Quantum SuperPAC Tubing set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set such as oxygenators, pumps, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support, for a maximum duration of 6 hours. Quantum SuperPAC Cardioplegia set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours. Quantum SuperPAC devices (all variants) are non-toxic, non-pyrogenic, and sterilized by ethylene oxide. Devices are intended for single use only and are not to be resterilized by the user. All the device surfaces in contact with blood are treated with a phosphorylcholine-based coating. Quantum SuperPAC devices (all variants) are mainly constituted of polyvinyl chloride (PVC) DOP free tubing and additional components composing the set; different variants are available, varying for tubing dimension and set configuration in order to address customer and surgical procedure specifications.

The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/ cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Devices are intended for adult patients. The Quantum PureFlow Cardioplegia Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool cardioplegic solution, to remove air and to monitor the temperature cardiopulmonary bypass (CPB) procedures up to 6 hours duration. Any blood to be treated must contain anticoagulant. Contact with cardioplegic solution for longer than this period is not permitted. Devices are intended for adult patients.

The Qura S.r.l. Quantum PureFlow Heat Exchangers described in this 510(k) are classified in two different product families: - -Quantum PureFlow Standard Heat Exchanger (HX-S); - -Quantum PureFlow Cardioplegia Heat Exchanger (HX-C). The devices have been designed to manage the temperature of blood (HX-S) or cardioplegic solution and physiological fluids (HX-C) during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours. HX-S is designed to: - 트 keep circulating blood at a specific temperature, depending on the type of surgery being performed; - maintain blood/patient thermoregulation during the CPB; - rewarm blood at the conclusion of the CPB in order to restore normothermic patient condition. HX-C is designed to: - I ensure heating/cooling of cardioplegic solution; - 트 ensure the cardioplegic solution cooling in order to arrest myocardium activity during-CPB; - remove air measure/monitor temperature in the circuit. Differently from the original submission K212688, Quantum PureFlow Heat Exchangers (both product families, HX-S and HX-C) described in this 510(k) have been designed to be powered by heater-cooler systems that use - Water or - 트 Glycol-based solution as Heat Transfer Fluid (HTF).

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U and Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use. Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U and Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use. Devices are intended for adult patients.

Quantum Perfusion Blood Oxygenator devices (acronym VT-C) consist of an oxygenator with an integrated arterial filter. The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.

The Quantum PureFlow Cardioplegia Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool cardioplegic solution, to remove air and to monitor the temperature cardiopulmonary bypass (CPB) procedures up to 6 hours duration. Any blood to be treated must contain anticoagulant. Contact with cardioplegic solution for longer than this period is not permitted. Devices are intended for adult patients. The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Devices are intended for adult patients.

The Qura S.r.l. Quantum PureFlow Heat Exchangers described in this 510(k) are classified in two different product families: - -Quantum PureFlow Standard Heat Exchanger (HX-S); - -Quantum PureFlow Cardioplegia Heat Exchanger (HX-C). The devices have been designed to manage the temperature of blood (HX-S) or cardioplegic solution and physiological fluids (HX-C) during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours. HX-S is designed to: - l keep circulating blood at a specific temperature, depending on the type of surgery being performed; - l maintain blood/patient thermoregulation during the CPB; - 트 rewarm blood at the conclusion of the CPB in order to restore normothermic patient condition. HX-C is designed to: - I ensure heating/cooling of cardioplegic solution; - 트 ensure the cardioplegic solution cooling in order to arrest myocardium activity during-CPB; - 트 remove air measure/monitor temperature in the circuit. - -Quantum PureFlow Heat Exchangers (both product families, HX-S and HX-C) described in this 510(k) have been designed to be powered by heater-cooler systems that use water as Heat Transfer Fluid (HTF).

Quantum Perfusion Blood Oxygenator ECC VT200-E1 and Quantum Perfusion Blood Oxygenator ECC VT160-E1 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. Quantum Perfusion Blood Oxygenator ECC VT200-E2 and Quantum Perfusion Blood Oxygenator ECC VT160-E2 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use. Devices are intended for adult patients.

The Quantum Perfusion Blood Oxygenator ECC (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours.. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethy|pentene (PMP). In this chamber, carbon dioxide moves from the blood to the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.