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510(k) DEN130045

HEARTFLOW FFRCT by Heartflow — Product Code PJA

DEN130045 is an FDA 510(k) premarket notification submitted by Heartflow for the device "HEARTFLOW FFRCT". The FDA issued a decision of De Novo Granted on November 26, 2014. The device falls under product code PJA (Coronary Vascular Physiologic Simulation Software), a Class II device regulated under 21 CFR 870.1415. Heartflow has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 26, 2014
Date Received
November 4, 2013
Clearance Type
Direct
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

  • K250902 — HeartFlow Analysis (July 18, 2025)
  • K213857 — HeartFlow Analysis (October 14, 2022)
  • K203329 — HeartFlow Analysis (January 8, 2021)
  • K190925 — HeartFlow FFRct Analysis (August 15, 2019)
  • K182035 — FFRct (December 6, 2018)
  • K161772 — FFRct (August 24, 2016)
  • K152733 — FFRct (January 13, 2016)

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)
  • K190925 — HeartFlow FFRct Analysis (August 15, 2019)
  • K182035 — FFRct (December 6, 2018)
  • K161772 — FFRct (August 24, 2016)
  • K152733 — FFRct (January 13, 2016)

FDA data resources