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FDA 510(k)

EM SINUS DILATION SYSTEM

K-Number: K132297 · 2013-11-05

ApplicantMedtronic Xomed, Inc.
Decision Date2013-11-05
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EM SINUS DILATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2013-11-05 under 510(k) number K132297. 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 EM SINUS DILATION SYSTEM?

EM SINUS DILATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-05. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K132297.

When did EM SINUS DILATION SYSTEM receive FDA 510(k) clearance?

EM SINUS DILATION SYSTEM received FDA 510(k) clearance on 2013-11-05, under 510(k) number K132297.

Who is the listed applicant for EM SINUS DILATION SYSTEM?

The FDA 510(k) record lists Medtronic Xomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EM SINUS DILATION SYSTEM?

The FDA product code for EM SINUS DILATION SYSTEM is LRC.

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Related Devices (Code: LRC)

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K230258BB 8 Sinus Dilation KitExcelent, Inc.K212774VenSure LightGuideIntersect Ent.K201398SINUSPRIME Dilation SystemStryker EntK201115Next Generation Balloon Dilation SystemAcclarent, Inc.K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbHK181546Dillard Nasal Balloon CatheterIntuit Medical Products, LLC

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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