Product code PFA— Cardiovascular
CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
- Classification name
- Non-Invasive Central Venous Manometer
- Device class
- Class 2
- Regulation
- 21 CFR 870.1140
- Advisory panel
- Cardiovascular
- Total cleared
- 2
- First cleared
- Most recent
FDA classification definition
“Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.”
Market context for product code PFA
FDA has cleared devices under product code PFA between 2013 and 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2015
- 2013
Top applicants under product code PFA
Recent clearances under product code PFA
Data sourced from openFDA. This site is unofficial and independent of the FDA.