| Device Type ID | 1982 |
| Device Name | Set, Dialysis, Single Needle (co-axial Flow) |
| 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 | LBW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1982 |
| Device | Set, Dialysis, Single Needle (co-axial Flow) |
| Product Code | LBW |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |