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PFAClass II

Non-Invasive Central Venous Manometer

21 CFR 870.1140 / Cardiovascular
FDA source (opens on fda.gov)

PFA is the FDA product code for Non-Invasive Central Venous Manometer, a class II device type, regulated under 21 CFR 870.1140. FDA's definition for this code reads: "Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PFA
Device name
Non-Invasive Central Venous Manometer
FDA definition
Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.
Regulation
21 CFR 870.1140
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PFA

By decision year
2 clearances under product code PFA with a decision year between 2013 and 2015, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFA by decision year
YearClearances
20131
20151

Applicants with the most clearances

Product code PFA
Applicants holding the most 510(k) clearances under product code PFA
ApplicantClearances
Mespere Lifesciences Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code