Shunt, Peritoneal
FDA product code KPM · Class II (moderate risk) · 21 CFR 876.5955 · Gastroenterology, Urology
19510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231096 | Automatic Continuous Effusion Shunt (ACES) System ACES SystemKPM · Traditional | Pleural Dynamics, Inc. | 08/18/2023SE |
| K170405 | BD Curve Ascites ShuntKPM · Traditional | Care Fusion | 11/02/2017SESK |
| K012235 | Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump ChamberKPM · Special | Denver Biomedical, Inc. | 10/04/2001SE |
| K011862 | Denver Ascites Shunt and Percutaneous Access Kit with Ascities ShuntKPM · Special | Denver Biomedical, Inc. | 07/12/2001SE |
| K011020 | Denver Pleural Effusion Shunt with External Pump ChamberKPM · Special | Denver Biomedicals, Inc. | 06/01/2001SE |
| K003451 | Denver Pak W/ Double-Valve Ascites Shunt,Denver Pak W/ Single-Valved Ascites Shunt…KPM · Special | Denver Biomedicals, Inc. | 01/02/2001SE |
| K973129 | Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access KitsKPM · Traditional | Denver Biomaterials, Inc. | 03/17/1998SE |
| K962814 | Denver Pleural Effusion Shunt with External Pump ChamberKPM · Traditional | Denver Biomaterials, Inc. | 04/14/1997SE |
| K913728 | Denver(R) Peritoneo-Subclavian ShuntKPM · Traditional | Denver Biomedicals, Inc. | 02/18/1994SE |
| K901360 | Leveen Peritineo-Venous ShuntKPM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/21/1990SE |
| K894794 | Agishi Ascites Pump Peritoneocaval Shunt PumpKPM · Traditional | Vitaid, Ltd. | 11/21/1989SE |
| K894756 | Denver Peritoneo-Venus ShuntKPM · Traditional | Codman & Shurtleff, Inc. | 09/29/1989SE |
| K880570 | Denver Pleuro-Peritoneal ShuntKPM · Traditional | Codman & Shurtleff, Inc. | 06/20/1988SE |
| K880401 | Denver Peritoneo-Venous ShuntKPM · Traditional | Codman & Shurtleff, Inc. | 05/31/1988SE |
| K842139 | The Denver Pleural-Peritoneal ShuntKPM · Traditional | Denver Biomedicals, Inc. | 08/27/1984SE |
| K822686 | Denver Peritoneo-Venous Shunt (Dp-Vs)KPM · Traditional | Denver Biomedicals, Inc. | 09/21/1982SE |
| K811183 | Denver Peritoneo-Venous ShuntKPM · Traditional | Denver Biomedicals, Inc. | 07/01/1981SE |
| K803258 | Cordis Hakim Ascites Valve SystemKPM · Traditional | Cordis Corp. | 01/15/1981SE |
| K770602 | Valve, Ascites, LaveenKPM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/15/1977SE |