Definition: The Device Is A Clamp Used To Close Off Needle Holes In The Arm Of A Dialysis Patient. The Clamp Applies Uniform Pressure To The Sites Of Needle Holes In The Patient's Arm Until The Holes Close. The Clamp Pressure Is Designed To Stop Bleeding Without
| Device Type ID | 2039 |
| Device Name | Clamp, Dialysis Arm |
| 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) Exempt |
| CFR Regulation Number | 876.5540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NOO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2039 |
| Device | Clamp, Dialysis Arm |
| Product Code | NOO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |