K161803

Substantially Equivalent

Traxcess .007 Mini Guidewire

Applicant: MicroVention, Inc.
Product code: MOF
Advisory panel: Cardiovascular
Date received: 2016-06-30
Decision date: 2016-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Tistin, CA, US

Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

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.