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FDA 510(k)

XPRESS BALLOON DEVICE

K-Number: K102003 · 2010-10-22

ApplicantEntellus Medical, Inc.
Decision Date2010-10-22
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

XPRESS BALLOON DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Entellus Medical, Inc.. It received FDA 510(k) clearance on 2010-10-22 under 510(k) number K102003. 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 XPRESS BALLOON DEVICE?

XPRESS BALLOON DEVICE is a medical device that received FDA 510(k) clearance on 2010-10-22. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K102003.

When did XPRESS BALLOON DEVICE receive FDA 510(k) clearance?

XPRESS BALLOON DEVICE received FDA 510(k) clearance on 2010-10-22, under 510(k) number K102003.

Who is the listed applicant for XPRESS BALLOON DEVICE?

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

What is the FDA product code for XPRESS BALLOON DEVICE?

The FDA product code for XPRESS BALLOON DEVICE is LRC.

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Other records listing Entellus Medical, Inc. 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.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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