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510(k) DEN200030

FEops HEARTguide by Feops NV — Product Code QQI

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 8, 2021
Date Received
May 7, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Cardiovascular Implant Simulation Software Device
Device Class
Class II
Regulation Number
870.1405
Review Panel
CV
Submission Type

An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.

Other clearances by Feops NV

  • K250635 — FEops HEARTguide Simulation Application (November 25, 2025)
  • K223855 — FEops HEARTguideTM, FEops HEARTguideTM ALPACA (June 6, 2023)
  • K214066 — FEops HEARTguide (February 25, 2022)

Other clearances for product code QQI

  • K250635 — FEops HEARTguide Simulation Application (November 25, 2025)
  • K223809 — PrecisionTAVI (v1.1) (May 30, 2023)
  • K214066 — FEops HEARTguide (February 25, 2022)