FDA Product Code
FDA Product Code KPM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5955
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231096 | Automatic Continuous Effusion Shunt (ACES) System ACES System | Pleural Dynamics, Inc. | 2023-08-18 | Traditional | PDF ↗ |
| K170405 | BD Curve Ascites Shunt | Care Fusion | 2017-11-02 | Traditional | PDF ↗ |
| K012235 | DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomedical, Inc. | 2001-10-04 | Special | PDF ↗ |
| K011862 | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | Denver Biomedical, Inc. | 2001-07-12 | Special | PDF ↗ |
| K011020 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomedicals, Inc. | 2001-06-01 | Special | PDF ↗ |
| 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 | Special | PDF ↗ |
| K973129 | DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS | Denver Biomaterials, Inc. | 1998-03-17 | Traditional | PDF ↗ |
| K962814 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | Denver Biomaterials, Inc. | 1997-04-14 | Traditional | PDF ↗ |
| K913728 | DENVER(R) PERITONEO-SUBCLAVIAN SHUNT | Denver Biomedicals, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K901360 | LEVEEN PERITINEO-VENOUS SHUNT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-08-21 | Traditional | PDF ↗ |
| K894794 | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP | Vitaid, Ltd. | 1989-11-21 | Traditional | PDF ↗ |
| K894756 | DENVER PERITONEO-VENUS SHUNT | Codman & Shurtleff, Inc. | 1989-09-29 | Traditional | PDF ↗ |
| K880570 | DENVER PLEURO-PERITONEAL SHUNT | Codman & Shurtleff, Inc. | 1988-06-20 | Traditional | PDF ↗ |
| K880401 | DENVER PERITONEO-VENOUS SHUNT | Codman & Shurtleff, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K842139 | THE DENVER PLEURAL-PERITONEAL SHUNT | Denver Biomedicals, Inc. | 1984-08-27 | Traditional | PDF ↗ |
| K822686 | DENVER PERITONEO-VENOUS SHUNT (DP-VS) | Denver Biomedicals, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K811183 | DENVER PERITONEO-VENOUS SHUNT | Denver Biomedicals, Inc. | 1981-07-01 | Traditional | PDF ↗ |
| K803258 | CORDIS HAKIM ASCITES VALVE SYSTEM | Cordis Corp. | 1981-01-15 | Traditional | PDF ↗ |
| K770602 | VALVE, ASCITES, LAVEEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-15 | Traditional | PDF ↗ |
Product code KPM · Class II · Gastroenterology, Urology. Data: openFDA.