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HeartFlow, Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories1
Latest FDA decision2025-07-18
TypeNumberDevice NameCodeDateActions
510(k) K250902 HeartFlow AnalysisPJA2025-07-18 View
510(k) K213857 HeartFlow AnalysisPJA2022-10-14 View
510(k) K203329 HeartFlow AnalysisPJA2021-01-08 View
510(k) K190925 HeartFlow FFRct AnalysisPJA2019-08-15 View
510(k) K182035 FFRctPJA2018-12-06 View
510(k) K161772 FFRctPJA2016-08-24 View
510(k) K152733 FFRctPJA2016-01-13 View
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