| Device Type ID | 1864 |
| Device Name | Cannula, A-v Shunt |
| Regulation Description | Blood Access Device And Accessories. |
| 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 | 876.5540 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | FIQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1864 |
| Device | Cannula, A-v Shunt |
| Product Code | FIQ |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |
| Device Problems | |
|---|---|
Fluid Leak | 1 |
| Total Device Problems | 1 |