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Angiographic Coronary Vascular Physiologic Simulation Software

FDA product code QEK · 2 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1415
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-12-19 – 2019-12-09

An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.

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