510(k) K183608— Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile

Substantially Equivalent

Scientia Vascular, LLC

Clearance details

Applicant: Scientia Vascular, LLC
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2018-12-26
Decision date: 2019-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Valley City, UT, 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.