Food and Drug Administration, HHS § 870.4290

§ 870.4220 or pieces of foreign material flowing in - machine console. the bloodstream which will obstruct (a) Identification. A cardiopulmonary circulation by blocking a vessel) out of bypass heart-lung machine console is a the . It is used in the arterial re- device that consists of a control panel turn line. and the electrical power and control (b) Classification. Class II (special circuitry for a heart-lung machine. The controls). The special control for this console is designed to interface with device is the FDA guidance document the basic units used in a gas exchange entitled ‘‘Guidance for system, including the pumps, Cardiopulmonary Bypass Arterial Line oxygenator, and heat exchanger. Blood Filter 510(k) Submissions.’’ (b) Classification. Class II (perform- ance standards). [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, § 870.4230 Cardiopulmonary bypass 2001] defoamer. (a) Identification. A cardiopulmonary § 870.4270 Cardiopulmonary bypass bypass defoamer is a device used in cardiotomy suction line blood filter. conjunction with an oxygenator during (a) Identification. A cardiopulmonary cardiopulmonary bypass surgery to re- bypass cardiotomy suction line blood move gas bubbles from the blood. filter is a device used as part of a gas (b) Classification. Class II (special exchange (oxygenator) system to filter controls). The special control for this nonbiologic particles and emboli (a device is the FDA guidance document blood clot or a piece of foreign mate- entitled ‘‘Guidance for Extracorporeal rial flowing in the bloodstream which Blood Circuit Defoamer 510(k) Submis- will obstruct circulation by blocking a sions.’’ vessel) out of the blood. This device is [45 FR 7907–7971, Feb. 5, 1980, as amended at intended for use in the cardiotomy suc- 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, tion line. 2001] (b) Classification. Class II (perform- § 870.4240 Cardiopulmonary bypass ance standards). heat exchanger. § 870.4280 Cardiopulmonary prebypass (a) Identification. A cardiopulmonary filter. bypass heat exchanger is a device, con- sisting of a heat exchange system used (a) Identification. A cardiopulmonary in extracorporeal circulation to warm prebypass filter is a device used during or cool the blood or perfusion fluid priming of the oxygenator circuit to flowing through the device. remove particulates or other debris (b) Classification. Class II (perform- from the circuit prior to initiating by- ance standards). pass. The device is not used to filter blood. § 870.4250 Cardiopulmonary bypass (b) Classification. Class II (perform- temperature controller. ance standards). (a) Identification. A cardiopulmonary bypass temperature controller is a de- § 870.4290 Cardiopulmonary bypass vice used to control the temperature of adaptor, stopcock, manifold, or fit- the fluid entering and leaving a heat ting. exchanger. (a) Identification. A cardiopulmonary (b) Classification. Class II (perform- bypass adaptor, stopcock, manifold, or ance standards). fitting is a device used in cardio- § 870.4260 Cardiopulmonary bypass ar- vascular diagnostic, surgical, and terial line blood filter. therapeutic applications to inter- (a) Identification. A cardiopulmonary connect tubing, catheters, or other de- bypass arterial line blood filter is a de- vices. vice used as part of a gas exchange (b) Classification. Class II (perform- (oxygenator) system to filter nonbio- ance standards). logic particles and emboli (blood clots

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