THE DENVER PLEURAL-PERITONEAL SHUNT
Device Facts
| Record ID | K842139 |
|---|---|
| Device Name | THE DENVER PLEURAL-PERITONEAL SHUNT |
| Applicant | Denver Biomedicals, Inc. |
| Product Code | KPM · Gastroenterology, Urology |
| Decision Date | Aug 27, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5955 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
