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Code of Federal Regulations Title 21. Food and Drugs § 21.876.5955 Peritoneo-venous shunt

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.876.5955 Peritoneo-venous shunt - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-876-5955/

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