Product code KPM
- Device name
- Shunt, Peritoneal
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5955
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231096 | Automatic Continuous Effusion Shunt (ACES) System ACES System | Pleural Dynamics, Inc. | 2023-08-18 |
| K170405 | BD Curve Ascites Shunt | Care Fusion | 2017-11-02 |
| K012235 | DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomedical, Inc. | 2001-10-04 |
| K011862 | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | Denver Biomedical, Inc. | 2001-07-12 |
| K011020 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomedicals, Inc. | 2001-06-01 |
| K003451 | DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T | Denver Biomedicals, Inc. | 2001-01-02 |
| K973129 | DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS | Denver Biomaterials, Inc. | 1998-03-17 |
| K962814 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomaterials, Inc. | 1997-04-14 |
| K913728 | DENVER(R) PERITONEO-SUBCLAVIAN SHUNT | Denver Biomedicals, Inc. | 1994-02-18 |
| K901360 | LEVEEN PERITINEO-VENOUS SHUNT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-08-21 |
| K894794 | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP | Vitaid, Ltd. | 1989-11-21 |
| K894756 | DENVER PERITONEO-VENUS SHUNT | Codman & Shurtleff, Inc. | 1989-09-29 |
| K880570 | DENVER PLEURO-PERITONEAL SHUNT | Codman & Shurtleff, Inc. | 1988-06-20 |
| K880401 | DENVER PERITONEO-VENOUS SHUNT | Codman & Shurtleff, Inc. | 1988-05-31 |
| K842139 | THE DENVER PLEURAL-PERITONEAL SHUNT | Denver Biomedicals, Inc. | 1984-08-27 |
| K822686 | DENVER PERITONEO-VENOUS SHUNT (DP-VS) | Denver Biomedicals, Inc. | 1982-09-21 |
| K811183 | DENVER PERITONEO-VENOUS SHUNT | Denver Biomedicals, Inc. | 1981-07-01 |
| K803258 | CORDIS HAKIM ASCITES VALVE SYSTEM | Cordis Corp. | 1981-01-15 |
| K770602 | VALVE, ASCITES, LAVEEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860011648109 | Automatic Continuous Effusion Shunt (ACES) System | Pleural Dynamics, Inc. | 2026-05-21 |
| 50885403242333 | N/A | CAREFUSION 2200, INC | 2018-07-26 |
| 50885403242326 | N/A | CAREFUSION 2200, INC | 2018-07-26 |
| 10885403242335 | N/A | CAREFUSION 2200, INC | 2018-07-26 |
| 10885403242328 | N/A | CAREFUSION 2200, INC | 2018-07-26 |
| 10885403471230 | Curve | CAREFUSION 2200, INC | 2018-03-16 |
| 10885403471223 | Curve | CAREFUSION 2200, INC | 2018-03-16 |
| 50885403471221 | N/A | CAREFUSION 2200, INC | 2018-03-16 |
| 10885403241208 | Curve | CAREFUSION 2200, INC | 2018-03-16 |
| 10885403460395 | N/A | CAREFUSION 2200, INC | 2018-03-14 |
| 50885403460393 | N/A | CAREFUSION 2200, INC | 2018-03-14 |
| 50885403076006 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 50885403076068 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 50885403076082 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 50885403076013 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 50885403076020 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 50885403076037 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 50885403076044 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403075995 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 50885403075993 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403222672 | Curve | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403219894 | Curve | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403076084 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403076077 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403076060 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403076046 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403076039 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403076022 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403076015 | Denver | CAREFUSION 2200, INC | 2017-06-12 |
| 10885403076008 | Denver | CAREFUSION 2200, INC | 2017-06-12 |