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a heart-lung bypass machine used in some types of open heart surgery belongs to which fda device category?

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The class-II FDA device category includes a heart-lung bypass machine used in some forms of open heart surgery.

The FDA's device category for cardiovascular devices includes three different groups of equipment. The classes-I, class-II, and class-III. On the basis of these classifications, they categorised the cardiovascular devices. A control panel and the machine's electrical power and control circuits make up the console for a heart-lung machine used in cardiopulmonary bypass. The console may be used to control the pumps, oxygenator, and heat exchanger, among other essential parts of a gas exchange system. Cardiopulmonary bypass (CPB) is a surgical procedure in which a machine temporarily replaces the heart and lungs to keep the body's blood and oxygen supply flowing.

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