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FDA 510(k)

RELIEVA SINUS BALLOON INFLATION DEVICE

K-Number: K052198 · 2005-08-31

ApplicantAcclarent, Inc.
Decision Date2005-08-31
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RELIEVA SINUS BALLOON INFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2005-08-31 under 510(k) number K052198. 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 RELIEVA SINUS BALLOON INFLATION DEVICE?

RELIEVA SINUS BALLOON INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 2005-08-31. The listed applicant is Acclarent, Inc.. The 510(k) number is K052198.

When did RELIEVA SINUS BALLOON INFLATION DEVICE receive FDA 510(k) clearance?

RELIEVA SINUS BALLOON INFLATION DEVICE received FDA 510(k) clearance on 2005-08-31, under 510(k) number K052198.

Who is the listed applicant for RELIEVA SINUS BALLOON INFLATION DEVICE?

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

What is the FDA product code for RELIEVA SINUS BALLOON INFLATION DEVICE?

The FDA product code for RELIEVA SINUS BALLOON INFLATION DEVICE is LRC.

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Other records listing Acclarent, Inc. as applicant

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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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