510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PHUUnclassified

Intra-Abdominal Pressure Monitoring Device

Unknown
FDA source (opens on fda.gov)

PHU is the FDA product code for Intra-Abdominal Pressure Monitoring Device. FDA's definition for this code reads: "Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PHU
Device name
Intra-Abdominal Pressure Monitoring Device
FDA definition
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code PHU

By decision year
2 clearances under product code PHU with a decision year between 2007 and 2021, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PHU by decision year
YearClearances
20071
20211

Applicants with the most clearances

Product code PHU
Applicants holding the most 510(k) clearances under product code PHU
ApplicantClearances
C.R. Bard Inc1
Sentinel Medical Technologies, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code