K213434

Substantially Equivalent

Elation Pulmonary Balloon Dilation Catheter

Applicant: Merit Medical Systems, Inc.
Product code: KTI
Advisory panel: Ear, Nose, Throat
Date received: 2021-10-22
Decision date: 2022-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

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.