Cleared Traditional

Relieva Tract Balloon Dilation System

K183090 · Acclarent, Inc. · Ear, Nose, Throat

Apr 2019

Decision

164d

Days

Class 1

Risk

About This 510(k) Submission

K183090 is an FDA 510(k) clearance for the Relieva Tract Balloon Dilation System, a Balloon, Nasal Airway (Class I — General Controls, product code QGK), submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on April 19, 2019, 164 days after receiving the submission on November 6, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K183090 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2018
Decision Date	April 19, 2019
Days to Decision	164 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	QGK — Balloon, Nasal Airway
Device Class	Class I — General Controls
CFR Regulation	21 CFR 874.4420
Definition	The Nasal Airway Balloon Is Intended To Provide Increased Intranasal Space To Facilitate Access For Endonasal And Transnasal Procedures And/or Temporarily Address Nasal Obstruction.