PHU — Intra-Abdominal Pressure Monitoring Device Class U

FDA Device Classification

Classification Details

Product Code
PHU
Device Class
Class U
Regulation Number
Submission Type
Review Panel
SU
Medical Specialty
Unknown
Implant
Yes

Definition

Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K210570sentinel medical technologiesTraumaGuard Intra-abdominal Pressure Sensing SystemOctober 29, 2021
K070201c.r. bardBARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001August 1, 2007