---
kind: "section"
citation: "21 C.F.R. § 870.5175"
title: "21"
number: "870.5175"
heading: "Septostomy catheter."
url: "https://uscodex.org/cfr/21/870.5175"
---

# §870.5175. Septostomy catheter.

- (a) **Identification.** A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.
- (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.