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FDA 510(k)

VenSure Balloon Device, VenSure Nav Balloon Device

K-Number: K201472 · 2020-08-26

ApplicantFiagon GmbH
Decision Date2020-08-26
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VenSure Balloon Device, VenSure Nav Balloon Device is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2020-08-26 under approval number K201472. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VenSure Balloon Device, VenSure Nav Balloon Device?

VenSure Balloon Device, VenSure Nav Balloon Device is a medical device that received FDA 510(k) clearance on 2020-08-26. It is manufactured by Fiagon GmbH. The 510(k) number is K201472.

When was VenSure Balloon Device, VenSure Nav Balloon Device approved by the FDA?

VenSure Balloon Device, VenSure Nav Balloon Device received FDA 510(k) clearance on 2020-08-26, under approval number K201472.

What company makes VenSure Balloon Device, VenSure Nav Balloon Device?

VenSure Balloon Device, VenSure Nav Balloon Device is manufactured by Fiagon GmbH.

What is the FDA product code for VenSure Balloon Device, VenSure Nav Balloon Device?

The FDA product code for VenSure Balloon Device, VenSure Nav Balloon Device is LRC.

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Official Source

View on FDA Database →

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

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