---
kind: "section"
citation: "21 C.F.R. § 876.5955"
title: "21"
number: "876.5955"
heading: "Peritoneo-venous shunt."
url: "https://uscodex.org/cfr/21/876.5955"
---

# §876.5955. Peritoneo-venous shunt.

- (a) **Identification.** A peritoneo-venous shunt is an implanted device that consists of a catheter and a pressure activated one-way valve. The catheter is implanted with one end in the peritoneal cavity and the other in a large vein. This device enables ascitic fluid in the peritoneal cavity to flow into the venous system for the treatment of intractable ascites.
- (b) **Classification.** Class II. The special controls for this device are FDA's:
  - (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
  - (2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
  - (3) **Backflow specification and testing to prevent reflux of blood into the shunt.**

## Notes

### Amendments

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, 2000]

### Authority

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

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, 2000]