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FDA 510(k)

Relieva UltirraNav Sinus Balloon Catheter

K-Number: K161698 · 2016-10-24

ApplicantAcclarent, Inc.
Decision Date2016-10-24
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Relieva UltirraNav Sinus Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K161698. 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 UltirraNav Sinus Balloon Catheter?

Relieva UltirraNav Sinus Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is Acclarent, Inc.. The 510(k) number is K161698.

When did Relieva UltirraNav Sinus Balloon Catheter receive FDA 510(k) clearance?

Relieva UltirraNav Sinus Balloon Catheter received FDA 510(k) clearance on 2016-10-24, under 510(k) number K161698.

Who is the listed applicant for Relieva UltirraNav Sinus Balloon Catheter?

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 UltirraNav Sinus Balloon Catheter?

The FDA product code for Relieva UltirraNav Sinus Balloon Catheter is LRC.

Other records listing Acclarent, 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.

K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemK230742ACCLARENT AERA Eustachian Tube Dilation SystemK231862TruDi® Navigation System V3 (FG-2000-00)K221037TruDi Shaver BladeK201115Next Generation Balloon Dilation SystemK201174TruDi Curette

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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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