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
10
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 10 devices under product code PJA between 2014 and 2026, filed by 4 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.