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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 the device name listed in this FDA 510(k) record. The listed applicant is Intuit Medical Products, LLC. It received FDA 510(k) clearance on 2020-01-03 under 510(k) 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. The listed applicant is Intuit Medical Products, LLC. The 510(k) number is K181546.

When did Dillard Nasal Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Dillard Nasal Balloon Catheter?

The FDA 510(k) record lists Intuit Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Intuit Medical Products, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153484Dillard Airway Dilatation System

Related Devices (Code: LRC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230258BB 8 Sinus Dilation KitExcelent, Inc.K212774VenSure LightGuideIntersect Ent.K201398SINUSPRIME Dilation SystemStryker EntK201115Next Generation Balloon Dilation SystemAcclarent, Inc.K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbHK190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.

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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