SDQ · Alfapump System
· Class 3
Overview
| Product Code | SDQ |
|---|---|
| Device Name | Alfapump System |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
The alfapump System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P230044 | alfapump System | Sequana Medical NV | Dec 20, 2024 | APPR |
Top Applicants
- Sequana Medical NV — 1 clearance
