| Device Type ID | 2580 |
| Device Name | Filter, Infusion Line |
| Regulation Description | Intravascular Administration Set. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FPB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2580 |
| Device | Filter, Infusion Line |
| Product Code | FPB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set. |
| CFR Regulation Number | 880.5440 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EMD MILLIPORE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 140 |
Filter | 53 |
Crack | 33 |
Leak / Splash | 28 |
Tube | 20 |
Tip | 12 |
System | 11 |
Break | 8 |
Disconnection | 5 |
Loose Or Intermittent Connection | 3 |
Device Damaged Prior To Use | 3 |
Filtration Problem | 3 |
Material Separation | 3 |
Reflux Within Device | 3 |
Hose | 3 |
No Flow | 2 |
Device Operates Differently Than Expected | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Component(s), Broken | 2 |
Defective Device | 1 |
Detachment Of Device Or Device Component | 1 |
Improper Flow Or Infusion | 1 |
Failure To Disconnect | 1 |
Separation Failure | 1 |
Junction | 1 |
Hole In Material | 1 |
Burst Container Or Vessel | 1 |
Fracture | 1 |
Port | 1 |
Material Integrity Problem | 1 |
Catheter | 1 |
Material Puncture / Hole | 1 |
Failure To Deliver | 1 |
Backflow | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 352 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Halyard Health, Inc | II | Mar-30-2018 |