21 CFR 876.5955
§ 876.5955 Peritoneo-venous shunt.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 876.5955, § 876.5955 Peritoneo-venous shunt, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90367
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.