---
kind: "section"
citation: "21 C.F.R. § 870.4400"
title: "21"
number: "870.4400"
heading: "Cardiopulmonary bypass blood reservoir."
url: "https://uscodex.org/cfr/21/870.4400"
---

# §870.4400. Cardiopulmonary bypass blood reservoir.

- (a) **Identification.** A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.
- (b) **Classification.** Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 870.9](/cfr/21/870.9.md).

## Notes

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

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

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]