FDA 510(k)

FEops HEARTguide

K-Number: K214066 · 2022-02-25

Decision Date2022-02-25

Product CodeQQI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FEops HEARTguide is the device name listed in this FDA 510(k) record. The listed applicant is Feops NV. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K214066. The device is classified under product code QQI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEops HEARTguide?

FEops HEARTguide is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Feops NV. The 510(k) number is K214066.

When did FEops HEARTguide receive FDA 510(k) clearance?

FEops HEARTguide received FDA 510(k) clearance on 2022-02-25, under 510(k) number K214066.

Who is the listed applicant for FEops HEARTguide?

The FDA 510(k) record lists Feops NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEops HEARTguide?

The FDA product code for FEops HEARTguide is QQI.

Other records listing Feops NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250635FEops HEARTguide Simulation Application K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACA

Related Devices (Code: QQI)

K250635FEops HEARTguide Simulation ApplicationFeops NV K223809PrecisionTAVI (v1.1)Dasi Simulations

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.