| Device Type ID | 1948 |
| Device Name | Set, Perfusion, Kidney, Disposable |
| Regulation Description | Isolated Kidney Perfusion And Transport System 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 | 876.5880 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KDL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1948 |
| Device | Set, Perfusion, Kidney, Disposable |
| Product Code | KDL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Isolated Kidney Perfusion And Transport System And Accessories. |
| CFR Regulation Number | 876.5880 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 2 |
Device Issue | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corp. | II | Nov-08-2016 |
| 2 | Organ Recovery Systems, Inc. | II | Jan-27-2017 |