K192442 is an FDA 510(k) clearance for the FFRangio. This device is classified as a Angiographic Coronary Vascular Physiologic Simulation Software (Class II - Special Controls, product code QEK).
Submitted by Cathworks, Ltd. (Kfar-Saba, IL). The FDA issued a Cleared decision on December 9, 2019, 94 days after receiving the submission on September 6, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1415. An Angiographic Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease..
| 510(k) Number | K192442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2019 |
| Decision Date | December 09, 2019 |
| Days to Decision | 94 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEK - Angiographic Coronary Vascular Physiologic Simulation Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1415 |
| Definition | An Angiographic Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease. |