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FDA 510(k)

MESIRE - Balloon Sinus Dilatation System

K-Number: K172737 · 2017-12-12

ApplicantM/S. Meril Life Sciences Private Limited
Decision Date2017-12-12
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MESIRE - Balloon Sinus Dilatation System is the device name listed in this FDA 510(k) record. The listed applicant is M/S. Meril Life Sciences Private Limited. It received FDA 510(k) clearance on 2017-12-12 under 510(k) number K172737. 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 MESIRE - Balloon Sinus Dilatation System?

MESIRE - Balloon Sinus Dilatation System is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is M/S. Meril Life Sciences Private Limited. The 510(k) number is K172737.

When did MESIRE - Balloon Sinus Dilatation System receive FDA 510(k) clearance?

MESIRE - Balloon Sinus Dilatation System received FDA 510(k) clearance on 2017-12-12, under 510(k) number K172737.

Who is the listed applicant for MESIRE - Balloon Sinus Dilatation System?

The FDA 510(k) record lists M/S. Meril Life Sciences Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MESIRE - Balloon Sinus Dilatation System?

The FDA product code for MESIRE - Balloon Sinus Dilatation System is LRC.

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 GmbHK181546Dillard Nasal Balloon CatheterIntuit Medical Products, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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