HeartFlow FFRct Analysis
FDA 510(k) K190925 · HeartFlow, Inc.
510(k) numberK190925
Submission
- Device name
- HeartFlow FFRct Analysis
- Applicant
- HeartFlow, Inc.
Redwood City, CA, US - Received
- April 9, 2019
- Decision date
- August 15, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PJA – Coronary Vascular Physiologic Simulation Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1415
- Specialty
- Cardiovascular
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Other 510(k)s with product code PJA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250902 | HeartFlow AnalysisPJA · Traditional | HeartFlow, Inc. | 07/18/2025SE |
| K213857 | HeartFlow AnalysisPJA · Traditional | HeartFlow, Inc. | 10/14/2022SE |
| K213657 | Deepvessel FFRPJA · Traditional | Keyamed Na, Inc. | 04/01/2022SE |
| K203329 | HeartFlow AnalysisPJA · Traditional | HeartFlow, Inc. | 01/08/2021SE |
| K182035 | FFRctPJA · Special | HeartFlow, Inc. | 12/06/2018SE |
| K161772 | FFRctPJA · Traditional | HeartFlow, Inc. | 08/24/2016SE |
| K152733 | FFRctPJA · Traditional | HeartFlow, Inc. | 01/13/2016SE |
More from HeartFlow, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250902 | HeartFlow AnalysisPJA · Traditional | 07/18/2025SE |
| K213857 | HeartFlow AnalysisPJA · Traditional | 10/14/2022SE |
| K203329 | HeartFlow AnalysisPJA · Traditional | 01/08/2021SE |
| K182035 | FFRctPJA · Special | 12/06/2018SE |
| K161772 | FFRctPJA · Traditional | 08/24/2016SE |
| K152733 | FFRctPJA · Traditional | 01/13/2016SE |
Questions and answers
When was HeartFlow FFRct Analysis cleared by the FDA?
HeartFlow FFRct Analysis (K190925) received a 510(k) decision of Substantially Equivalent on August 15, 2019, 128 days after the submission was received.
What is the product code of K190925?
The FDA product code is PJA – Coronary Vascular Physiologic Simulation Software, a Class II (moderate risk) device regulated under 21 CFR 870.1415.