K182149 is an FDA 510(k) clearance for the FFRangio System. 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 19, 2018, 133 days after receiving the submission on August 8, 2018.
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 | K182149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2018 |
| Decision Date | December 19, 2018 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| 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. |