Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 870 - Cardiovascular Devices |
Subpart E - Cardiovascular Surgical Devices |
§ 870.4240 - Cardiopulmonary bypass heat exchanger.
Latest version.
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§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a) Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.
(b) Classification. Class II (performance standards).