QEK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Angiographic Coronary Vascular Physiologic Simulation Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1415
- Medical specialty
- Cardiovascular
- FDA definition
- An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
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| Record | Firm | Date |
|---|---|---|
| FFRangio (K192442) | Cathworks, Ltd. | 2019-12-09 |
| FFRangio System (K182149) | Cathworks, Ltd. | 2018-12-19 |
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