← Product Code [KPM](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM) · K822686

# DENVER PERITONEO-VENOUS SHUNT (DP-VS) (K822686)

_Denver Biomedicals, Inc. · KPM · Sep 21, 1982 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K822686

## Device Facts

- **Applicant:** Denver Biomedicals, Inc.
- **Product Code:** [KPM](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM.md)
- **Decision Date:** Sep 21, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5955
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K822686](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K822686)

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