| Device Type ID | 1973 |
| Device Name | Shunt, Peritoneal |
| Regulation Description | Peritoneo-venous Shunt. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5955 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KPM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1973 |
| Device | Shunt, Peritoneal |
| Product Code | KPM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Peritoneo-venous Shunt. |
| CFR Regulation Number | 876.5955 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |