PJAClass II
Coronary Vascular Physiologic Simulation Software
Cardiovascular · 21 CFR 870.1415
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
MDR events139All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances9All time
Recent MDR events
139 adverse event reports on file
- HEARTFLOW ANALYSISJul 8, 2026MalfunctionHeartflow, Inc.3021637148-2026-00007
- HEARTFLOW ANALYSISJul 2, 2026MalfunctionHeartflow, Inc.3021637148-2026-00006
- HEARTFLOW ANALYSISApr 15, 2026MalfunctionHeartflow, Inc.3021637148-2026-00005
- HEARTFLOW ANALYSISApr 9, 2026MalfunctionHeartflow, Inc.3021637148-2026-00004
- HEARTFLOW ANALYSISMar 6, 2026InjuryHeartflow, Inc.3021637148-2026-00003
- HEARTFLOW ANALYSISJan 17, 2026MalfunctionHeartflow, Inc.3021637148-2026-00001
- HEARTFLOW ANALYSISJan 17, 2026MalfunctionHeartflow, Inc.3021637148-2026-00002
- HEARTFLOW ANALYSISOct 28, 2025MalfunctionHeartflow, Inc.3021637148-2025-00017
- HEARTFLOW ANALYSISOct 16, 2025InjuryHeartflow, Inc.3021637148-2025-00016
- HEARTFLOW ANALYSISSep 11, 2025MalfunctionHeartflow, Inc.3021637148-2025-00015
Event type breakdown
Malfunction127
Injury12
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- HeartFlow, Inc.Jul 18, 2025
K250902 · HeartFlow Analysis
- HeartFlow, Inc.Oct 14, 2022
K213857 · HeartFlow Analysis
- Keyamed Na, Inc.Apr 1, 2022
K213657 · DEEPVESSEL FFR
- HeartFlow, Inc.Jan 8, 2021
K203329 · HeartFlow Analysis
- HeartFlow, Inc.Aug 15, 2019
K190925 · HeartFlow FFRct Analysis
- HeartFlow, Inc.Dec 6, 2018
K182035 · FFRct
- HeartFlow, Inc.Aug 24, 2016
K161772 · FFRct
- HeartFlow, Inc.Jan 13, 2016
K152733 · FFRct