| Device Type ID | 1917 |
| Device Name | Apparatus, Hemoperfusion, Sorbent |
| Regulation Description | Sorbent Hemoperfusion System. |
| 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 | 876.5870 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FLD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1917 |
| Device | Apparatus, Hemoperfusion, Sorbent |
| Product Code | FLD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sorbent Hemoperfusion System. |
| CFR Regulation Number | 876.5870 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GAMBRO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GAMBRO RENAL PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 23 |
Disconnection | 19 |
Connector | 7 |
Device Contamination With Chemical Or Other Material | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Tube | 2 |
Fitting Problem | 1 |
Filter | 1 |
Misassembled | 1 |
Loss Of Or Failure To Bond | 1 |
| Total Device Problems | 61 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corporation | II | Jan-24-2018 |
| 2 | Gambro Renal Products, Incorporated | II | Aug-13-2014 |