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510(k) K213657

DEEPVESSEL FFR by Keyamed Na, Inc. — Product Code PJA

K213657 is an FDA 510(k) premarket notification submitted by Keyamed Na, Inc. for the device "DEEPVESSEL FFR". The FDA issued a decision of Substantially Equivalent on April 1, 2022. The device falls under product code PJA (Coronary Vascular Physiologic Simulation Software), a Class II device regulated under 21 CFR 870.1415.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2022
Date Received
November 19, 2021
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 for product code PJA

  • 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)
  • DEN130045 — HEARTFLOW FFRCT (November 26, 2014)

FDA data resources