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FDA 510(k)

RELIEVA ULTIRRA Sinus Balloon Catheter

K-Number: K190525 · 2019-05-03

ApplicantAcclarent, Inc.
Decision Date2019-05-03
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RELIEVA ULTIRRA Sinus Balloon Catheter is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2019-05-03 under approval number K190525. 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 ULTIRRA Sinus Balloon Catheter?

RELIEVA ULTIRRA Sinus Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-05-03. It is manufactured by Acclarent, Inc.. The 510(k) number is K190525.

When was RELIEVA ULTIRRA Sinus Balloon Catheter approved by the FDA?

RELIEVA ULTIRRA Sinus Balloon Catheter received FDA 510(k) clearance on 2019-05-03, under approval number K190525.

What company makes RELIEVA ULTIRRA Sinus Balloon Catheter?

RELIEVA ULTIRRA Sinus Balloon Catheter is manufactured by Acclarent, Inc..

What is the FDA product code for RELIEVA ULTIRRA Sinus Balloon Catheter?

The FDA product code for RELIEVA ULTIRRA Sinus Balloon Catheter is LRC.

Related Clinical Trials

NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter NOT_YET_RECRUITING

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 K171687Relieva SpinPlus Nav Balloon Sinuplasty System K180948TruDi NAV Suction Instruments

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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 K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc. K181838Sinusway Dilation System3nt Medical , Ltd.

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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