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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 the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2020-08-26 under 510(k) 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. The listed applicant is Fiagon GmbH. The 510(k) number is K201472.

When did VenSure Balloon Device, VenSure Nav Balloon Device receive FDA 510(k) clearance?

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

Who is the listed applicant for VenSure Balloon Device, VenSure Nav Balloon Device?

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

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.

Other records listing Fiagon GmbH 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.

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Related Devices (Code: LRC)

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.

K230258BB 8 Sinus Dilation KitExcelent, Inc.K212774VenSure LightGuideIntersect Ent.K201398SINUSPRIME Dilation SystemStryker EntK201115Next Generation Balloon Dilation SystemAcclarent, Inc.K181546Dillard Nasal Balloon CatheterIntuit Medical Products, LLCK190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.

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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