Definition: To Treat And Provide Hemodialysis Therapy At Home For Chronic Renal Failure Patients.
| Device Type ID | 2080 |
| Device Name | Hemodialysis System For Home Use |
| Physical State | Complex Machine Consisting Of Pumps, Monitors, And Tubing. |
| Technical Method | A Machine That Dialyzes The Patient's Blood. |
| Target Area | Connects To The Patient's Blood Stream |
| Regulation Description | High Permeability Hemodialysis 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 | 876.5860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ONW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2080 |
| Device | Hemodialysis System For Home Use |
| Product Code | ONW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | High Permeability Hemodialysis System. |
| CFR Regulation Number | 876.5860 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 33 |
Device Operates Differently Than Expected | 22 |
Mechanical Problem | 19 |
Fluid Leak | 16 |
Reflux Within Device | 15 |
Mechanical Jam | 4 |
Use Of Device Problem | 4 |
Partial Blockage | 3 |
Pressure Problem | 2 |
Pumping Stopped | 2 |
Device Alarm System | 2 |
Thermal Decomposition Of Device | 2 |
Disconnection | 2 |
Failure To Deliver | 2 |
Failure To Adhere Or Bond | 2 |
Misconnection | 1 |
Inadequate Ultra Filtration | 1 |
Electronic Property Issue | 1 |
Power Problem | 1 |
Fracture | 1 |
Contamination / Decontamination Problem | 1 |
Connection Problem | 1 |
Kinked | 1 |
Computer Software Problem | 1 |
High PH | 1 |
Pumping Problem | 1 |
| Total Device Problems | 141 |