Code of Federal Regulations · Section
§ 870.4390 — Cardiopulmonary Bypass Pump Tubing
21 C.F.R. § 870.4390
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351