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510(k) DEN200030

FEops HEARTguide by Feops NV — Product Code QQI

DEN200030 is an FDA 510(k) premarket notification submitted by Feops NV for the device "FEops HEARTguide". The FDA issued a decision of De Novo Granted on Sep 8, 2021. The device falls under product code QQI (Interventional Cardiovascular Implant Simulation Software Device), a Class II device regulated under 21 CFR 870.1405. Feops NV has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
Sep 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 (Nov 25, 2025)
  • K223855 — FEops HEARTguideTM, FEops HEARTguideTM ALPACA (Jun 6, 2023)
  • K214066 — FEops HEARTguide (Feb 25, 2022)

Other clearances for product code QQI

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

FDA data resources