PFA

Non-Invasive Central Venous Manometer

Product code

PFA

Device name

Non-Invasive Central Venous Manometer

Device class

Class 2

21 CFR

21 CFR 870.1140

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).