Cleared Traditional

K214066 - FEops HEARTguide (FDA 510(k) Clearance)

K214066 · Feops NV · Cardiovascular device
Feb 2022
Decision
60d
Days
Class 2
Risk

K214066 is an FDA 510(k) clearance for the FEops HEARTguide. This device is classified as a Interventional Cardiovascular Implant Simulation Software Device (Class II - Special Controls, product code QQI).

Submitted by Feops NV (Gent-Zwijnaarde, BE). The FDA issued a Cleared decision on February 25, 2022, 60 days after receiving the submission on December 27, 2021.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1405. 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..

Submission Details

510(k) Number K214066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date February 25, 2022
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QQI - Interventional Cardiovascular Implant Simulation Software Device
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.1405
Definition 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.