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FDA 510(k)

INSPIRA AIR BALLOON DILATION SYSTEM

K-Number: K110218 · 2011-03-31

ApplicantAcclarent, Inc.
Decision Date2011-03-31
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INSPIRA AIR BALLOON DILATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2011-03-31 under 510(k) number K110218. 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 INSPIRA AIR BALLOON DILATION SYSTEM?

INSPIRA AIR BALLOON DILATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-31. The listed applicant is Acclarent, Inc.. The 510(k) number is K110218.

When did INSPIRA AIR BALLOON DILATION SYSTEM receive FDA 510(k) clearance?

INSPIRA AIR BALLOON DILATION SYSTEM received FDA 510(k) clearance on 2011-03-31, under 510(k) number K110218.

Who is the listed applicant for INSPIRA AIR BALLOON DILATION SYSTEM?

The FDA 510(k) record lists Acclarent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSPIRA AIR BALLOON DILATION SYSTEM?

The FDA product code for INSPIRA AIR BALLOON DILATION SYSTEM is KTI.

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Other records listing Acclarent, Inc. 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.

K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemK230742ACCLARENT AERA Eustachian Tube Dilation SystemK231862TruDi® Navigation System V3 (FG-2000-00)K221037TruDi Shaver BladeK201115Next Generation Balloon Dilation SystemK201174TruDi Curette

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Related Devices (Code: KTI)

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.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation

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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