2 devices · 1 company · 2018 to 2019
Product code QEK: Angiographic Coronary Vascular Physiologic Simulation Software
2 devices under product code QEK, 2018 to 2019, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Angiographic Coronary Vascular Physiologic Simulation Software. 21 CFR 870.1415, Class II. An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease. MAUDE held 0 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.
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| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| FFRangioK192442 · 510(k) | CathWorks Ltd | Cardiovascular | database entry | |
| FFRangio SystemK182149 · 510(k) | CathWorks Ltd | Cardiovascular | database entry |
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