MERIT ONE SNARE SYSTEM— 510(k) K122088

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K122088 for MERIT ONE SNARE SYSTEM, Substantially Equivalent on 2012-12-05. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code MMX
Advisory panel: Cardiovascular
Date received: 2012-07-16
Decision date: 2012-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

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Adverse events under product code MMX

product code MMX

Death: 3
Total: 3

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.