21 C.F.R. § 870.4390 Cardiopulmonary bypass pump tubing.
Title 21 - Food and Drugs
(a) Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4390 Cardiopulmonary bypass pump tubing.