| Device Type ID | 1876 |
| Device Name | Dialyzer, Capillary, Hollow Fiber |
| Regulation Description | Hemodialysis 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 | 876.5820 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FJI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1876 |
| Device | Dialyzer, Capillary, Hollow Fiber |
| Product Code | FJI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemodialysis System And Accessories. |
| CFR Regulation Number | 876.5820 [🔎] |
| Device Problems | |
|---|---|
Fluid Leak | 1180 |
Adverse Event Without Identified Device Or Use Problem | 203 |
Insufficient Information | 22 |
Crack | 17 |
Material Rupture | 14 |
Occlusion Within Device | 8 |
Device Issue | 5 |
Leak / Splash | 4 |
Break | 3 |
Filtration Problem | 2 |
Improper Chemical Reaction | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Device Handling Problem | 1 |
Complete Blockage | 1 |
Hole In Material | 1 |
Material Separation | 1 |
Use Of Device Problem | 1 |
No Flow | 1 |
Appropriate Term/Code Not Available | 1 |
Material Integrity Problem | 1 |
Burst Container Or Vessel | 1 |
Infusion Or Flow Problem | 1 |
| Total Device Problems | 1470 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Fresenius Medical Care Renal Therapies Group, LLC | II | Apr-05-2016 |