K213857 is an FDA 510(k) clearance for the HeartFlow Analysis. 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 October 14, 2022, 308 days after receiving the submission on December 10, 2021.
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 | K213857 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2021 |
| Decision Date | October 14, 2022 |
| Days to Decision | 308 days |
| Submission Type | Traditional |
| 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. |