KPM · Shunt, Peritoneal
Gastroenterology, Urology · 21 CFR 876.5955 · Class 2
Overview
| Product Code | KPM |
|---|---|
| Device Name | Shunt, Peritoneal |
| Regulation | 21 CFR 876.5955 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 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 | Automatic Continuous Effusion Shunt (ACES) System ACES System | Pleural Dynamics, Inc. | Aug 18, 2023 | SESE |
| K170405 | BD Curve Ascites Shunt | Care Fusion | Nov 2, 2017 | SESK |
| K012235 | DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomedical, Inc. | Oct 4, 2001 | SESE |
| K011862 | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | Denver Biomedical, Inc. | Jul 12, 2001 | SESE |
| K011020 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomedicals, Inc. | Jun 1, 2001 | SESE |
| K003451 | 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 | DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS | Denver Biomaterials, Inc. | Mar 17, 1998 | SESE |
| K962814 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomaterials, Inc. | Apr 14, 1997 | SESE |
| K913728 | DENVER(R) PERITONEO-SUBCLAVIAN SHUNT | Denver Biomedicals, Inc. | Feb 18, 1994 | SESE |
| K901360 | LEVEEN PERITINEO-VENOUS SHUNT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 21, 1990 | SESE |
| K894794 | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP | Vitaid, Ltd. | Nov 21, 1989 | SESE |
| K894756 | DENVER PERITONEO-VENUS SHUNT | Codman & Shurtleff, Inc. | Sep 29, 1989 | SESE |
| K880570 | DENVER PLEURO-PERITONEAL SHUNT | Codman & Shurtleff, Inc. | Jun 20, 1988 | SESE |
| K880401 | DENVER PERITONEO-VENOUS SHUNT | Codman & Shurtleff, Inc. | May 31, 1988 | SESE |
| K842139 | THE DENVER PLEURAL-PERITONEAL SHUNT | Denver Biomedicals, Inc. | Aug 27, 1984 | SESE |
| K822686 | DENVER PERITONEO-VENOUS SHUNT (DP-VS) | Denver Biomedicals, Inc. | Sep 21, 1982 | SESE |
| K811183 | DENVER PERITONEO-VENOUS SHUNT | Denver Biomedicals, Inc. | Jul 1, 1981 | SESE |
| K803258 | CORDIS HAKIM ASCITES VALVE SYSTEM | Cordis Corp. | Jan 15, 1981 | SESE |
| K770602 | 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
