Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5955](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5955) → KPM — Shunt, Peritoneal # KPM · Shunt, Peritoneal _Gastroenterology, Urology · 21 CFR 876.5955 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM ## Overview - **Product Code:** KPM - **Device Name:** Shunt, Peritoneal - **Regulation:** [21 CFR 876.5955](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5955) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) - **Implant:** yes ## 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. ## Classification Rationale Class II. The special controls for this device are FDA's: ## 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. ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K231096](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K231096.md) | Automatic Continuous Effusion Shunt (ACES) System ACES System | Pleural Dynamics, Inc. | Aug 18, 2023 | SESE | | [K170405](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K170405.md) | BD Curve Ascites Shunt | Care Fusion | Nov 2, 2017 | SESK | | [K012235](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K012235.md) | DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomedical, Inc. | Oct 4, 2001 | SESE | | [K011862](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K011862.md) | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | Denver Biomedical, Inc. | Jul 12, 2001 | SESE | | [K011020](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K011020.md) | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomedicals, Inc. | Jun 1, 2001 | SESE | | [K003451](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K003451.md) | DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T | Denver Biomedicals, Inc. | Jan 2, 2001 | SESE | | [K973129](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K973129.md) | DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS | Denver Biomaterials, Inc. | Mar 17, 1998 | SESE | | [K962814](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K962814.md) | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomaterials, Inc. | Apr 14, 1997 | SESE | | [K913728](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K913728.md) | DENVER(R) PERITONEO-SUBCLAVIAN SHUNT | Denver Biomedicals, Inc. | Feb 18, 1994 | SESE | | [K901360](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K901360.md) | LEVEEN PERITINEO-VENOUS SHUNT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 21, 1990 | SESE | | [K894794](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K894794.md) | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP | Vitaid, Ltd. | Nov 21, 1989 | SESE | | [K894756](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K894756.md) | DENVER PERITONEO-VENUS SHUNT | Codman & Shurtleff, Inc. | Sep 29, 1989 | SESE | | [K880570](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K880570.md) | DENVER PLEURO-PERITONEAL SHUNT | Codman & Shurtleff, Inc. | Jun 20, 1988 | SESE | | [K880401](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K880401.md) | DENVER PERITONEO-VENOUS SHUNT | Codman & Shurtleff, Inc. | May 31, 1988 | SESE | | [K842139](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K842139.md) | THE DENVER PLEURAL-PERITONEAL SHUNT | Denver Biomedicals, Inc. | Aug 27, 1984 | SESE | | [K822686](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K822686.md) | DENVER PERITONEO-VENOUS SHUNT (DP-VS) | Denver Biomedicals, Inc. | Sep 21, 1982 | SESE | | [K811183](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K811183.md) | DENVER PERITONEO-VENOUS SHUNT | Denver Biomedicals, Inc. | Jul 1, 1981 | SESE | | [K803258](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K803258.md) | CORDIS HAKIM ASCITES VALVE SYSTEM | Cordis Corp. | Jan 15, 1981 | SESE | | [K770602](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM/K770602.md) | VALVE, ASCITES, LAVEEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 15, 1977 | SESE | ## Top Applicants - Denver Biomedicals, Inc. — 6 clearances - Codman & Shurtleff, Inc. — 3 clearances - Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances - Denver Biomaterials, Inc. — 2 clearances - Denver Biomedical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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