| Device Type ID | 2205 |
| Device Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| 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 | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MDP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2205 |
| Device | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
| Product Code | MDP |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 23 |
Leak / Splash | 6 |
Patient-Device Incompatibility | 5 |
Fluid Leak | 3 |
Break | 1 |
Crack | 1 |
Biocompatibility | 1 |
Air Leak | 1 |
Hole In Material | 1 |
Coagulation In Device Or Device Ingredient | 1 |
Misassembled | 1 |
Connection Problem | 1 |
| Total Device Problems | 45 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Gambro Renal Products, Incorporated | II | Aug-13-2014 |