PHU · Intra-Abdominal Pressure Monitoring Device
· Class U
Overview
| Product Code | PHU |
|---|---|
| Device Name | Intra-Abdominal Pressure Monitoring Device |
| Device Class | Class U |
| Review Panel | |
| Implant | Yes |
Identification
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210570 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | Oct 29, 2021 | SESE |
| K070201 | BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 | C.R. Bard, Inc. | Aug 1, 2007 | SESE |
Top Applicants
- C.R. Bard, Inc. — 1 clearance
- Sentinel Medical Technologies, LLC — 1 clearance