| Device Type ID | 2576 |
| Device Name | Catheter, Umbilical Artery |
| Regulation Description | Intravascular Catheter. |
| 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 | 880.5200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FOS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2576 |
| Device | Catheter, Umbilical Artery |
| Product Code | FOS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Catheter. |
| CFR Regulation Number | 880.5200 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 116 |
Fluid Leak | 31 |
Break | 26 |
Crack | 15 |
Catheter | 13 |
Fracture | 6 |
Material Fragmentation | 6 |
Hole In Material | 3 |
Hub | 3 |
Infusion Or Flow Problem | 3 |
Appropriate Term/Code Not Available | 3 |
Obstruction Of Flow | 3 |
Structural Problem | 2 |
Material Puncture / Hole | 2 |
Use Of Device Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Device Operates Differently Than Expected | 2 |
Material Integrity Problem | 2 |
Housing | 2 |
Material Rupture | 2 |
Material Perforation | 2 |
Filtration Problem | 1 |
Device Markings / Labelling Problem | 1 |
Material Separation | 1 |
Patient Device Interaction Problem | 1 |
Air Leak | 1 |
Complete Blockage | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Migration Or Expulsion Of Device | 1 |
Connection Problem | 1 |
| Total Device Problems | 255 |