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FDA 510(k)

Relieva Tract Balloon Dilation System

K-Number: K183090 · 2019-04-19

ApplicantAcclarent, Inc.
Decision Date2019-04-19
Product CodeQGK
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Relieva Tract Balloon Dilation System is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2019-04-19 under approval number K183090. The device is classified under product code QGK. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Relieva Tract Balloon Dilation System?

Relieva Tract Balloon Dilation System is a medical device that received FDA 510(k) clearance on 2019-04-19. It is manufactured by Acclarent, Inc.. The 510(k) number is K183090.

When was Relieva Tract Balloon Dilation System approved by the FDA?

Relieva Tract Balloon Dilation System received FDA 510(k) clearance on 2019-04-19, under approval number K183090.

What company makes Relieva Tract Balloon Dilation System?

Relieva Tract Balloon Dilation System is manufactured by Acclarent, Inc..

What is the FDA product code for Relieva Tract Balloon Dilation System?

The FDA product code for Relieva Tract Balloon Dilation System is QGK.

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Other Devices by Acclarent, Inc.

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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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