Dillard Airway Dilatation System— 510(k) K153484

Name: FDA 510(k) clearance K153484
Creator: U.S. Food and Drug Administration
Published: 2016-07-27

Substantially Equivalent

Intuit Medical Products, LLC

FDA 510(k) clearance K153484 for Dillard Airway Dilatation System, Substantially Equivalent on 2016-07-27. Applicant: Intuit Medical Products, LLC. Device class: 2.

Clearance details

Applicant: Intuit Medical Products, LLC
Product code: Code KTI
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2015-12-03
Decision date: 2016-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Hill, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTI

view all

K261274 — EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes +1 more2026-07-24
K251478 — ClearTip TBNA Type2026-04-16
K254040 — LungFlow Basket Catheter2026-03-12
K251402 — LIA-1 Catheter (542-1)2025-12-19
K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-012025-10-08

More clearances from Intuit Medical Products, LLC

view all

K181546 — Dillard Nasal Balloon Catheter2020-01-03
K143738 — DSS Sinusplasty Balloon Catheter2015-08-27

Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

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.