CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR876.5955]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES

Subpart F - Therapeutic Devices

Sec. 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]