Definition: Abdominal Intracompartmental Pressure Monitoring Using Bladder Pressure As A Surrogate For Abdominal Pressure.
| Device Type ID | 5962 |
| Device Name | Intra-abdominal Pressure Monitoring Device |
| Physical State | Urological Catheter, Pressure Sensing Device. |
| Technical Method | Monitoring Abdominal Intracompartmental Pressure With A Urological Catheter |
| Target Area | Urological |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | PHU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5962 |
| Device | Intra-abdominal Pressure Monitoring Device |
| Product Code | PHU |
| Device Problems | |
|---|---|
Defective Device | 6 |
Break | 2 |
Nonstandard Device | 2 |
Accessory Incompatible | 2 |
Volume Accuracy Problem | 1 |
Inaccurate Flow Rate | 1 |
| Total Device Problems | 14 |