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The Dideco D732 MICRO 27 Ph.I.S.I.O. with 27 micron screen with phosphoryIcholine coating is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The fitter is used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D732 MICRO 27 Ph.I.S.I.O. is sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 7.0 liters/minute. The D732 MICRO 27 Ph.I.S.I.O. is an Adult Arterial Filter with 27 micron filter screen designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 27 microns from the arterial line perfusate. The D732 MICRO 27 Ph.I.S.I.O. is a modified version of the currently marketed D732 MICRO 20. The modification consists of coating all blood contact surfaces with phosphoryicholine additive that improves the blood compatibility of the substrate materials and change of the pleated polyester filter screen pore size from 20 to 27 micron. Other than this change the D 732 MICRO 27 Ph.I.S.I.O. and the D 732 MICRO 20 are identical in design, materials, and manufacturing processes.

The Dideco D731 MICRO 20 Ph.I.S.I.O., with 20 micron screen with phosphorylcholine coating and the Dideco D733 MICRO 40 Ph.I.S.I.O., with 40 micron screen with phosphorylcholine coating are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are sterile, non-pyrogenic disposable filters for use in the arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 5.0 liters/minute. The D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are Pediatric Arterial Filters with 20 and 40 micron filter screens designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 20 and 40 microns respectively from the arterial line perfusate. The D731 MICRO 20 Ph.J.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are a modified version of the currently marketed D731/D733 MICRO. The modification consists of coating all blood contact surfaces with phosphoryIcholine additive that improves the blood compatibility of the substrate materials. Other than this change the D 731/D733 MICRÓ Ph.I.S.I.O. and the D 731/D733 MICRO are identical in design, materials, and manufacturing processes.

The ECC.O is intended for use in patients who undergo surgical procedures requiring extracorporeal gas exchange support and blood temperature control with a maximum blood flow rate of 5 liters/minute. ECC.O must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. ECC.O is intended for use with the Stockert Centrifugal Pump Console.

The ECC.O System with Integrated Venous Air Removal Device, Centrifugal Blood Pump, Pump Bracket. Hollow Fiber Oxygenator and Heat Exchanger is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. ECC.O consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger connected to a venous air removal device (defoamer) (Ideal Mimesys' Venous Air Removal Device, K032040), a centrifugal pump (Ideal Mimesys' Centrifugal Pump, K032040) and a pump bracket.

The Performa Adult Hollow Fiber Membrane Oxygenator is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

The Performa Adult Hollow Fiber Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.

The Dideco D 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters /minute. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for 6 hours or less.

The D 905 EOS Hollow Fiber Oxygenator With Integrated Hardshell Venous/Cardiotomy Reservoir (hereafter referred to as the D 905 EOS) is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell venous/cardiotomy reservoir. The device is a modified version of the currently marketed D 903 Avant 2 Ph.I.S.I.O (K033323) predicate device (hereafter referred to as the Avant Ph.1.S.I.O.). The modification is limited to an overall reduction in the size of the device. The reduction in size enables the device to be better suited for the pediatric and small adult patient population.

The Dideco D731 MICRO 20 with 20 micron screen and the Dideco D733 MICRO 40 with 40 micron screen are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that maybe intrough the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D731 MICRO 20 and D733 MICRO 40 are sterile, non-pyrogenic disposable filters for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 5.0 liters/minutes. The D731 MICRO 20 and D733 MICRO 40 are Pediatric Arterial Filters with 20 and 40 micron filter screens designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 20 and 40 microns respectively from the arterial line perfusate. The maximum blood flow rate has been increased to 5.0 liters/minute.

The Dideco D 903 Avant Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated on other provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from to tient's veins (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for six hours or less.

The D 903 AVANT and D 903 AVANT 2 Ph.I.S.I.O, hereafter referred to as the AVANT, are hollow fiber membrane oxygenators with integral heat exchanger and a hardshell cardiotomy/venous reservoir. The D 903 AVANT 2 Ph.I.S.I.O. is the phosphorylcholine coated version of the same AVANT oxygenator. The change covered by this submission is limited to extending the intended use of the AVANT (uncoated and coated versions) in order to allow the use of active venous drainage with vacuum. No modifications are being made to the devices themselves except an addition to the indications for use and instructions for use.

The Dideco D735 MICRO 20 with 20 micron screen and the Dideco D736 MICRO 40 with 40 micron screen are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D735 MICRO 20 and D736 MICRO 40 are sterile, non-pyrogenic disposable filters for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 2.5 liters/minute. The D735 MICRO 20 and D736 MICRO 40 are Newborn-Infant Arterial Filters with 20 and 40 micron filter screens designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 20 and 40 microns respectively from the arterial line perfusate. The bypass connector has been eliminated in the modified versions of the D736 predicate devices resulting in enhanced ergonomics. In addition, the maximum blood flow rate has been increased to 2.5 liters/minute, in order to be consistent with the maximum flow rate of the cleared D736 MICRO Ph.I.S.I.O. modified device (K002493).

The MVR 1200 PC is intended for use as a storage reservoir for blood in an extracorporeal bypass circuit for periods up to six hours.

Sorin Monolyth Venous Reservoir 1200 PC with Phosphorilcholine coating (hereafter referred to as the MVR 1200 PC) is a soft, flexible polyviny chloride plastic bag designed for use during extracorporeal bypass surgery as in-line venous bag reservoir. Blood contact surfaces of the MVR 1200 PC have been coated with phosphorylcholine (PC) coating improves blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.

Ideal Mimesys is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control. Ideal Mimesys must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. Ideal Mimesys is intended for use with the Stöckert Centrifugal Pump Console.

IDEAL MIMESYS System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter Mimesys Treated (PhosphoryIcholine coating hereinafter called PC coating) is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. IDEAL MIMESYS consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter (Synthesis Mimesys Adult Membrane Oxygenator, K031223) connected to an active venous air removal device (defoamer), a centrifugal pump (Cobe Revolution Centrifugal Blood Pump with PC coating, K030462) and a pump bracket.