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FDA 510(k)

Dillard Nasal Balloon Catheter

K-Number: K181546 · 2020-01-03

ApplicantIntuit Medical Products, LLC
Decision Date2020-01-03
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Dillard Nasal Balloon Catheter is a medical device manufactured by Intuit Medical Products, LLC. It received FDA 510(k) clearance on 2020-01-03 under approval number K181546. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dillard Nasal Balloon Catheter?

Dillard Nasal Balloon Catheter is a medical device that received FDA 510(k) clearance on 2020-01-03. It is manufactured by Intuit Medical Products, LLC. The 510(k) number is K181546.

When was Dillard Nasal Balloon Catheter approved by the FDA?

Dillard Nasal Balloon Catheter received FDA 510(k) clearance on 2020-01-03, under approval number K181546.

What company makes Dillard Nasal Balloon Catheter?

Dillard Nasal Balloon Catheter is manufactured by Intuit Medical Products, LLC.

What is the FDA product code for Dillard Nasal Balloon Catheter?

The FDA product code for Dillard Nasal Balloon Catheter is LRC.

Related Clinical Trials

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Other Devices by Intuit Medical Products, LLC

K153484Dillard Airway Dilatation System

Related Devices (Code: LRC)

K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc. K160770Vent-Os Sinus Dilation familySinusys Corporation K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc. K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc. K181838Sinusway Dilation System3nt Medical , Ltd.

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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