8 devices · 4 companies · 2016 to 2025
Product code PJA: Coronary Vascular Physiologic Simulation Software
8 devices under product code PJA, 2016 to 2025, from 4 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 8 here), the regulation, and MAUDE report counts by product code.
Coronary Vascular Physiologic Simulation Software. 21 CFR 870.1415, Class II. A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease. MAUDE held 151 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| HeartFlow AnalysisK250902 · 510(k) | HeartFlow, Inc. | Cardiovascular | database entry | |
| HeartFlow AnalysisK213857 · 510(k) | HeartFlow, Inc. | Cardiovascular | database entry | |
| DEEPVESSEL FFRK213657 · 510(k) | KeyaMed NA Inc. | Cardiovascular | database entry | |
| HeartFlow AnalysisK203329 · 510(k) | HeartFlow, Inc. | Cardiovascular | database entry | |
| HeartFlow FFRct AnalysisK190925 · 510(k) | HeartFlow, Inc. | Cardiovascular | database entry | |
| FFRctK182035 · 510(k) | HeartFlow, Inc | Cardiovascular | database entry | |
| FFRctK161772 · 510(k) | HEARTFLOW, INC. | Cardiovascular | database entry | |
| FFRctK152733 · 510(k) | HEARTFLOW, INC. | Cardiovascular | database entry |
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