KPM — Shunt, Peritoneal Class II
FDA product code KPM covers "Shunt, Peritoneal", a Class II medical device regulated under 21 CFR 876.5955. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPM
- Device Class
- Class II
- Regulation Number
- 876.5955
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231096 | pleural dynamics | Automatic Continuous Effusion Shunt (ACES) System ACES System | August 18, 2023 |
| K170405 | care fusion | BD Curve Ascites Shunt | November 2, 2017 |
| K012235 | denver biomedical | DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PU | October 4, 2001 |
| K011862 | denver biomedical | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | July 12, 2001 |
| K011020 | denver biomedicals | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | June 1, 2001 |
| K003451 | denver biomedicals | DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHU | January 2, 2001 |
| K973129 | denver biomaterials | DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS | March 17, 1998 |
| K962814 | denver biomaterials | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | April 14, 1997 |
| K913728 | denver biomedicals | DENVER(R) PERITONEO-SUBCLAVIAN SHUNT | February 18, 1994 |
| K901360 | bd becton dickinson vacutainer systems preanalytic | LEVEEN PERITINEO-VENOUS SHUNT | August 21, 1990 |
| K894794 | vitaid | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP | November 21, 1989 |
| K894756 | codman and shurtleff | DENVER PERITONEO-VENUS SHUNT | September 29, 1989 |
| K880570 | codman and shurtleff | DENVER PLEURO-PERITONEAL SHUNT | June 20, 1988 |
| K880401 | codman and shurtleff | DENVER PERITONEO-VENOUS SHUNT | May 31, 1988 |
| K842139 | denver biomedicals | THE DENVER PLEURAL-PERITONEAL SHUNT | August 27, 1984 |
| K822686 | denver biomedicals | DENVER PERITONEO-VENOUS SHUNT (DP-VS) | September 21, 1982 |
| K811183 | denver biomedicals | DENVER PERITONEO-VENOUS SHUNT | July 1, 1981 |
| K803258 | cordis | CORDIS HAKIM ASCITES VALVE SYSTEM | January 15, 1981 |
| K770602 | bd becton dickinson vacutainer systems preanalytic | VALVE, ASCITES, LAVEEN | April 15, 1977 |