21 CFR 870.4390 - Cardiopulmonary bypass pump tubing.

Regulations last checked for updates: Oct 18, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart E [§ 870.4075 - § 870.4885]

§ 870.4390 - Cardiopulmonary bypass pump tubing.

(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).

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

cite as: 21 CFR 870.4390