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
- 510(k)
- 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 | Aug 18, 2023 |
| K170405 | Care Fusion | BD Curve Ascites Shunt | Nov 2, 2017 |
| K012235 | Denver Biomedical | DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL… | Oct 4, 2001 |
| K011862 | Denver Biomedical | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | Jul 12, 2001 |
| K011020 | Denver Biomedicals | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Jun 1, 2001 |
| K003451 | Denver Biomedicals | DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES… | Jan 2, 2001 |
| K973129 | Denver Biomaterials | DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS | Mar 17, 1998 |
| K962814 | Denver Biomaterials | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Apr 14, 1997 |
| K913728 | Denver Biomedicals | DENVER(R) PERITONEO-SUBCLAVIAN SHUNT | Feb 18, 1994 |
| K901360 | Bd Becton Dickinson Vacutainer Systems Preanalytic | LEVEEN PERITINEO-VENOUS SHUNT | Aug 21, 1990 |
| K894794 | Vitaid | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP | Nov 21, 1989 |
| K894756 | Codman And Shurtleff | DENVER PERITONEO-VENUS SHUNT | Sep 29, 1989 |
| K880570 | Codman And Shurtleff | DENVER PLEURO-PERITONEAL SHUNT | Jun 20, 1988 |
| K880401 | Codman And Shurtleff | DENVER PERITONEO-VENOUS SHUNT | May 31, 1988 |
| K842139 | Denver Biomedicals | THE DENVER PLEURAL-PERITONEAL SHUNT | Aug 27, 1984 |
| K822686 | Denver Biomedicals | DENVER PERITONEO-VENOUS SHUNT (DP-VS) | Sep 21, 1982 |
| K811183 | Denver Biomedicals | DENVER PERITONEO-VENOUS SHUNT | Jul 1, 1981 |
| K803258 | Cordis | CORDIS HAKIM ASCITES VALVE SYSTEM | Jan 15, 1981 |
| K770602 | Bd Becton Dickinson Vacutainer Systems Preanalytic | VALVE, ASCITES, LAVEEN | Apr 15, 1977 |