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FDA 510(k)

RELIEVA SINUS BALLOON DILATION CATHETER

K-Number: K043527 · 2005-04-05

ApplicantExploramed Nc1, Inc.
Decision Date2005-04-05
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RELIEVA SINUS BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Exploramed Nc1, Inc.. It received FDA 510(k) clearance on 2005-04-05 under 510(k) number K043527. 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 DILATION CATHETER?

RELIEVA SINUS BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2005-04-05. The listed applicant is Exploramed Nc1, Inc.. The 510(k) number is K043527.

When did RELIEVA SINUS BALLOON DILATION CATHETER receive FDA 510(k) clearance?

RELIEVA SINUS BALLOON DILATION CATHETER received FDA 510(k) clearance on 2005-04-05, under 510(k) number K043527.

Who is the listed applicant for RELIEVA SINUS BALLOON DILATION CATHETER?

The FDA 510(k) record lists Exploramed Nc1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RELIEVA SINUS BALLOON DILATION CATHETER?

The FDA product code for RELIEVA SINUS BALLOON DILATION CATHETER is LRC.

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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

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

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