K182035 is an FDA 510(k) clearance for the FFRct. This device is classified as a Coronary Vascular Physiologic Simulation Software (Class II - Special Controls, product code PJA).
Submitted by HeartFlow, Inc. (Redwood City, US). The FDA issued a Cleared decision on December 6, 2018, 129 days after receiving the submission on July 30, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1415. A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease..
| 510(k) Number | K182035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2018 |
| Decision Date | December 06, 2018 |
| Days to Decision | 129 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PJA - Coronary Vascular Physiologic Simulation Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1415 |
| Definition | A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease. |