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U.S. Department of Health and Human Services

Product Classification

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Device intra-abdominal pressure monitoring device
Definition Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
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
Product CodePHU
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible