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HeartFlow, Inc.

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

Total Devices7
Categories1
Latest Approval2025-07-18
TypeNumberDevice NameCodeDate
510(k) K250902 HeartFlow Analysis PJA 2025-07-18 View
510(k) K213857 HeartFlow Analysis PJA 2022-10-14 View
510(k) K203329 HeartFlow Analysis PJA 2021-01-08 View
510(k) K190925 HeartFlow FFRct Analysis PJA 2019-08-15 View
510(k) K182035 FFRct PJA 2018-12-06 View
510(k) K161772 FFRct PJA 2016-08-24 View
510(k) K152733 FFRct PJA 2016-01-13 View
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