---
kind: "section"
citation: "21 C.F.R. § 870.4270"
title: "21"
number: "870.4270"
heading: "Cardiopulmonary bypass cardiotomy suction line blood filter."
url: "https://uscodex.org/cfr/21/870.4270"
---

# §870.4270. Cardiopulmonary bypass cardiotomy suction line blood filter.

- (a) **Identification.** A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.
- (b) **Classification.** Class II (performance standards).

## Notes

### 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.