Aristotle 18 Guidewire; Aristotle 24 Guidewire— 510(k) K231954

Substantially Equivalent

Scientia Vascular, Inc.

FDA 510(k) clearance K231954 for Aristotle 18 Guidewire; Aristotle 24 Guidewire, Substantially Equivalent on 2023-08-01. Applicant: Scientia Vascular, Inc..

Clearance details

Applicant: Scientia Vascular, Inc.
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2023-07-03
Decision date: 2023-08-01
Decision: Substantially Equivalent
Clearance type: Special
Location: West Valley City, UT, US

Download summary PDF View on FDA.gov ↗

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.