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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 870 - Cardiovascular Devices |
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Subpart E - Cardiovascular Surgical Devices |
§ 870.4370 - Roller-type cardiopulmonary bypass blood pump.
Latest version.
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§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a) Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.
(b) Classification. Class II (performance standards).