FDA Product Code PHU: Intra-abdominal Pressure Monitoring Device
Abdominal Intracompartmental Pressure Monitoring Using Bladder Pressure As A Surrogate For Abdominal Pressure.
Leading manufacturers include C.R. Bard, Inc. and Sentinel Medical Technologies, LLC.
2
Total
2
Cleared
218d
Avg days
2007
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Intra-abdominal Pressure Monitoring Device Devices (Product Code PHU)
2 devices
Cleared
Oct 29, 2021
TraumaGuard Intra-abdominal Pressure Sensing System
Sentinel Medical Technologies, LLC
General & Plastic Surgery
245d
Cleared
Aug 01, 2007
BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001
C.R. Bard, Inc.
General & Plastic Surgery
191d
About Product Code PHU - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code PHU since 2007, with 2 receiving FDA clearance (average review time: 218 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.