QEKClass II
Angiographic Coronary Vascular Physiologic Simulation Software
Cardiovascular · 21 CFR 870.1415
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
MDR events0All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances2All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
2 clearances for this product code