---
kind: "section"
citation: "21 C.F.R. § 870.1220"
title: "21"
number: "870.1220"
heading: "Electrode recording catheter or electrode recording probe."
url: "https://uscodex.org/cfr/21/870.1220"
---

# §870.1220. Electrode recording catheter or electrode recording probe.

- (a) **Identification.** An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.
- (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.