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FDA 510(k)

Relieva SpinPlus Nav Balloon Sinuplasty System

K-Number: K171687 · 2017-09-05

ApplicantAcclarent, Inc.
Decision Date2017-09-05
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Relieva SpinPlus Nav Balloon Sinuplasty System is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2017-09-05 under approval number K171687. 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 SpinPlus Nav Balloon Sinuplasty System?

Relieva SpinPlus Nav Balloon Sinuplasty System is a medical device that received FDA 510(k) clearance on 2017-09-05. It is manufactured by Acclarent, Inc.. The 510(k) number is K171687.

When was Relieva SpinPlus Nav Balloon Sinuplasty System approved by the FDA?

Relieva SpinPlus Nav Balloon Sinuplasty System received FDA 510(k) clearance on 2017-09-05, under approval number K171687.

What company makes Relieva SpinPlus Nav Balloon Sinuplasty System?

Relieva SpinPlus Nav Balloon Sinuplasty System is manufactured by Acclarent, Inc..

What is the FDA product code for Relieva SpinPlus Nav Balloon Sinuplasty System?

The FDA product code for Relieva SpinPlus Nav Balloon Sinuplasty System is LRC.

Related Clinical Trials

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Other Devices by Acclarent, Inc.

K161697Acclarent NavWire Sinus Navigation Guidewire K161698Relieva UltirraNav Sinus Balloon Catheter DEN150056Acclarent Aera Eustachian Tube Balloon Dilation System K153341Relieva Scout Multi-Sinus Dilation System K180948TruDi NAV Suction Instruments K173628Acclarent ENT Navigation System

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Related Devices (Code: LRC)

K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc. K160770Vent-Os Sinus Dilation familySinusys Corporation K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc. K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited K181838Sinusway Dilation System3nt Medical , Ltd. K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.

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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