| Device Type ID | 1950 |
| Device Name | System, Perfusion, Kidney |
| 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 | KDN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1950 |
| Device | System, Perfusion, Kidney |
| Product Code | KDN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Isolated Kidney Perfusion And Transport System And Accessories. |
| CFR Regulation Number | 876.5880 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PARAGONIX TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
PRESERVATION SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UNITED THERAPEUTICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XVIVO PERFUSION AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Microbial Contamination Of Device | 4 |
Fluid Leak | 1 |
Defective Component | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Preservation Solutions, Inc. | II | Apr-16-2018 |