21 CFR § 870.4370 Cardiovascular Devices

§ 870.4370 Roller-type cardiopulmonary bypass blood pump.

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

⚠ 3 pending changes to Part 870

(a) Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.

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

← § 870.4360 Nonroller-type blood pump.§ 870.4380 Cardiopulmonary bypass pump speed control. →