ONE Snare Endovascular Microsnare System— 510(k) K142265

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K142265 for ONE Snare Endovascular Microsnare System, Substantially Equivalent on 2014-11-13. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant
Merit Medical Systems, Inc.
Product code
Code MMX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Galway, IE
Download summary PDFView on FDA.gov ↗

Adverse events under product code MMX

product code MMX
Death
3
Total
3

Source: openFDA MAUDE database, through . 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.