21 CFR 870.4310 - Cardiopulmonary bypass coronary pressure gauge.

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]

§ 870.4310 - Cardiopulmonary bypass coronary pressure gauge.

(a) Identification. A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure the pressure of the blood perfusing the coronary arteries.

(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 870.4310