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510(k) K190925

HeartFlow FFRct Analysis by HeartFlow, Inc. — Product Code PJA

K190925 is an FDA 510(k) premarket notification submitted by HeartFlow, Inc. for the device "HeartFlow FFRct Analysis". The FDA issued a decision of Substantially Equivalent on August 15, 2019. The device falls under product code PJA (Coronary Vascular Physiologic Simulation Software), a Class II device regulated under 21 CFR 870.1415. HeartFlow, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2019
Date Received
April 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coronary Vascular Physiologic Simulation Software
Device Class
Class II
Regulation Number
870.1415
Review Panel
CV
Submission Type

A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.

Other clearances by HeartFlow, Inc.

  • K250902 — HeartFlow Analysis (July 18, 2025)
  • K213857 — HeartFlow Analysis (October 14, 2022)
  • K203329 — HeartFlow Analysis (January 8, 2021)
  • K182035 — FFRct (December 6, 2018)
  • K161772 — FFRct (August 24, 2016)
  • K152733 — FFRct (January 13, 2016)
  • DEN130045 — HEARTFLOW FFRCT (November 26, 2014)

Other clearances for product code PJA

  • K250902 — HeartFlow Analysis (July 18, 2025)
  • K213857 — HeartFlow Analysis (October 14, 2022)
  • K213657 — DEEPVESSEL FFR (April 1, 2022)
  • K203329 — HeartFlow Analysis (January 8, 2021)
  • K182035 — FFRct (December 6, 2018)
  • K161772 — FFRct (August 24, 2016)
  • K152733 — FFRct (January 13, 2016)
  • DEN130045 — HEARTFLOW FFRCT (November 26, 2014)

FDA data resources