Merit ONE Snare System— 510(k) K193507

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K193507 for Merit ONE Snare System, Substantially Equivalent on 2020-01-17. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code MMX
Advisory panel: Cardiovascular
Date received: 2019-12-18
Decision date: 2020-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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.