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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.

Synthesis Mimesys is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 um. Synthesis Mimesys is an adult oxygenator intended for use in operations on adult patients. Synthesis Mimesys must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

SYNTHESIS MIMESYS Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated is a high efficiency microporous hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter and connected to a hardshell cardiotomy venous reservoir.

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

The Ideal, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. The Ideal consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter (Synthesis Adult Membrane Oxygenator, K022450), connected to an active venous air removal device (defoamer), a centrifuqal pump (Cobe Revolution Centrifyial Blood Pump. K011835) and a pump bracket.

The Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.

The Dideco DHF Hemoconcentrator is a hollow fiber type hemoconcentrator consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing.

The Synthesis is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 um. The Synthesis is an adult oxygenator intended for use in operations on adult patients. Synthesis must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

The Synthesis Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and with an arterial filter and connected to a an hardshell venous/cardiotomy reservoir.

The Dideco electa is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood, and pre-operative sequestration (with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.

The Dideco electa consists of hardware and disposables. It is the next generation of the Dideco autotransfusion device family. The main elements of the hardware include the centrifuge, blood pump, automatic clamps, control and monitoring sensors, and a user interface (display panel and keyboard). The modifications to the disposables are the addition of a bar code to the addition of a tubing cassette to simplify disposables installation.