| Device Type ID | 2573 |
| Device Name | Device, Occlusion, Umbilical |
| Regulation Description | Umbilical Occlusion Device. |
| 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) Exempt |
| CFR Regulation Number | 880.5950 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FOD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2573 |
| Device | Device, Occlusion, Umbilical |
| Product Code | FOD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Umbilical Occlusion Device. |
| CFR Regulation Number | 880.5950 [🔎] |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 14 |
Device Operates Differently Than Expected | 12 |
Improper Or Incorrect Procedure Or Method | 12 |
Failure To Adhere Or Bond | 2 |
Appropriate Term/Code Not Available | 1 |
Break | 1 |
| Total Device Problems | 42 |