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FDA 510(k)

Elation Pulmonary Balloon Dilation

K-Number: K161392 · 2016-09-01

ApplicantMerit Medical Systems, Inc.
Decision Date2016-09-01
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Elation Pulmonary Balloon Dilation is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161392. 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 Elation Pulmonary Balloon Dilation?

Elation Pulmonary Balloon Dilation is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K161392.

When did Elation Pulmonary Balloon Dilation receive FDA 510(k) clearance?

Elation Pulmonary Balloon Dilation received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161392.

Who is the listed applicant for Elation Pulmonary Balloon Dilation?

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

What is the FDA product code for Elation Pulmonary Balloon Dilation?

The FDA product code for Elation Pulmonary Balloon Dilation is KTI.

Related Clinical Trials

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.

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Related Devices (Code: KTI)

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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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