Cleared Traditional

Dillard Nasal Balloon Catheter

K181546 · Intuit Medical Products, LLC · Ear, Nose, Throat
Jan 2020
Decision
570d
Days
Class 1
Risk

About This 510(k) Submission

K181546 is an FDA 510(k) clearance for the Dillard Nasal Balloon Catheter, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Intuit Medical Products, LLC (Sugar Hill, US). The FDA issued a Cleared decision on January 3, 2020, 570 days after receiving the submission on June 12, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K181546 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2018
Decision Date January 03, 2020
Days to Decision 570 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LRC — Instrument, Ent Manual Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420