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FDA 510(k)

RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER

K-Number: K073041 · 2008-03-11

ApplicantAcclarent, Inc.
Decision Date2008-03-11
Product CodeKAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2008-03-11 under 510(k) number K073041. The device is classified under product code KAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER?

RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2008-03-11. The listed applicant is Acclarent, Inc.. The 510(k) number is K073041.

When did RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER receive FDA 510(k) clearance?

RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER received FDA 510(k) clearance on 2008-03-11, under 510(k) number K073041.

Who is the listed applicant for RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER?

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 RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER?

The FDA product code for RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER is KAM.

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Other records listing Acclarent, Inc. as applicant

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Related Devices (Code: KAM)

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.

K110687RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)Acclarent, Inc.K093594MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACERAcclarent, Inc.K083574RELIEVA STRATUS MICROFLOW SPACERAcclarent, Inc.K072891SINUS SPACERAcclarent, Inc.K071845RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100AAcclarent, Inc.K062458ETHMOID SINUS SPACERAcclarent, 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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