FDA 510(k) Applications Submitted by HeartFlow, Inc.
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K190925 | 04/09/2019 | HeartFlow FFRct Analysis | HeartFlow, Inc. |
| K161772 | 06/28/2016 | FFRct | HEARTFLOW, INC. |
| K152733 | 09/22/2015 | FFRct | HEARTFLOW, INC. |
| K203329 | 11/12/2020 | HeartFlow Analysis | HeartFlow, Inc. |
| K213857 | 12/10/2021 | HeartFlow Analysis | HeartFlow, Inc. |
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