21 CFR § 870.4205 Cardiovascular Devices

§ 870.4205 Cardiopulmonary bypass bubble detector.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(a) Identification. A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.

(b) Classification. Class II (performance standards).

← § 870.4200 Cardiopulmonary bypass accessory equipment.§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing. →