1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 870
  5. subpart E
  6. § 870.4380

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

§ 870.4380 - Cardiopulmonary bypass pump speed control.

(a) Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.

(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 870.4380