21 CFR § 876.5955 - Peritoneo-venous shunt.

---
identifier: "/us/cfr/t21/s876.5955"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 876.5955 - Peritoneo-venous shunt."
title_number: 21
title_name: "Food and Drugs"
section_number: "876.5955"
section_name: "Peritoneo-venous shunt."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "876"
part_name: "GASTROENTEROLOGY-UROLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53023, Nov. 23, 1983, unless otherwise noted."
cfr_part: "876"
---


# 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.

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