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FDA 510(k)

Dillard Airway Dilatation System

K-Number: K153484 · 2016-07-27

ApplicantIntuit Medical Products, LLC
Decision Date2016-07-27
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Dillard Airway Dilatation System is a medical device manufactured by Intuit Medical Products, LLC. It received FDA 510(k) clearance on 2016-07-27 under approval number K153484. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dillard Airway Dilatation System?

Dillard Airway Dilatation System is a medical device that received FDA 510(k) clearance on 2016-07-27. It is manufactured by Intuit Medical Products, LLC. The 510(k) number is K153484.

When was Dillard Airway Dilatation System approved by the FDA?

Dillard Airway Dilatation System received FDA 510(k) clearance on 2016-07-27, under approval number K153484.

What company makes Dillard Airway Dilatation System?

Dillard Airway Dilatation System is manufactured by Intuit Medical Products, LLC.

What is the FDA product code for Dillard Airway Dilatation System?

The FDA product code for Dillard Airway Dilatation System is KTI.

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Other Devices by Intuit Medical Products, LLC

K181546Dillard Nasal Balloon Catheter

Related Devices (Code: KTI)

K161392Elation Pulmonary Balloon DilationMerit Medical Systems, Inc. K152922ViziShot FLEXSpiration, Inc. K171232PeriView FLEXOlympus Surgical Technologies America K170759CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation K163469ViziShot 2 FLEXOlympus Surgical Technologies America K181193PeriView FLEXOlympus Surgical Technologies America

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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