Dillard Nasal Balloon Catheter— 510(k) K181546

Name: FDA 510(k) clearance K181546
Creator: U.S. Food and Drug Administration
Published: 2020-01-03

Substantially Equivalent

Intuit Medical Products, LLC

FDA 510(k) clearance K181546 for Dillard Nasal Balloon Catheter, Substantially Equivalent on 2020-01-03. Applicant: Intuit Medical Products, LLC. Device class: 1.

Clearance details

Applicant: Intuit Medical Products, LLC
Product code: Code LRC
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 2018-06-12
Decision date: 2020-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Hill, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRC

product code LRC

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.