| Device Type ID | 1863 |
| Device Name | Subsystem, Water Purification |
| Regulation Description | Water Purification System For Hemodialysis. |
| 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 | 876.5665 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FIP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1863 |
| Device | Subsystem, Water Purification |
| Product Code | FIP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Water Purification System For Hemodialysis. |
| CFR Regulation Number | 876.5665 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMERIWATER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FRESENIUS MEDICAL CARE NORTH AMERICA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAR COR | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VIVONIC GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Thermal Decomposition Of Device | 3 |
Flushing Problem | 2 |
Filtration Problem | 2 |
Fitting Problem | 2 |
Material Integrity Problem | 2 |
Device Reprocessing Problem | 2 |
Material Disintegration | 2 |
Contamination / Decontamination Problem | 2 |
Loss Of Or Failure To Bond | 2 |
Melted | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Electrical /Electronic Property Problem | 1 |
Sparking | 1 |
Water Purification System | 1 |
Misconnection | 1 |
Component Incompatible | 1 |
Misassembly By Users | 1 |
Overheating Of Device | 1 |
Misassembly During Maintenance / Repair | 1 |
Solenoid | 1 |
| Total Device Problems | 30 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Mar Cor Purification | II | May-06-2014 |
| 2 | Mar Cor Purification | II | Mar-14-2014 |
| 3 | Mar Cor Purification | II | Mar-13-2014 |