Elation Pulmonary Balloon Dilation— 510(k) K161392

Name: FDA 510(k) clearance K161392
Creator: U.S. Food and Drug Administration
Published: 2016-09-01

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K161392 for Elation Pulmonary Balloon Dilation, Substantially Equivalent on 2016-09-01. Applicant: Merit Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code KTI
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2016-05-19
Decision date: 2016-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.