DeviceClearance

Product code PJA— Cardiovascular

FFRct

Classification name
Coronary Vascular Physiologic Simulation Software
Device class
Class 2
Regulation
21 CFR 870.1415
Advisory panel
Cardiovascular
Total cleared
9
First cleared
Most recent

FDA classification definition

“A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.”

— U.S. Food and Drug Administration, device classification record for product code PJA under 21 CFR 870.1415, via openFDA

Market context for product code PJA

FDA has cleared 9 devices under product code PJA between 2014 and 2025, filed by 3 applicant companies. 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

Top applicants under product code PJA

Recent clearances under product code PJA

Data sourced from openFDA. This site is unofficial and independent of the FDA.