DeviceClearance

Aristotle Mini Guidewire— 510(k) K260223

Substantially Equivalent

Scientia Vascular, Inc.

FDA 510(k) clearance K260223 for Aristotle Mini Guidewire, Substantially Equivalent on 2026-08-06. Applicant: Scientia Vascular, Inc.. Device class: 2.

Summary

Scientia Vascular's Aristotle Mini Guidewire is filed under product code MOF, neurovasculature catheter guide wires. The record gives no sizes or model numbers.

Class II, 21 CFR 870.1330. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.

Scientia filed from West Valley City, Utah. The decision came 192 calendar days after FDA received it (January 26 to August 6, 2026), and it was substantially equivalent.

Clearance details

Applicant
Scientia Vascular, Inc.
Product code
Product code MOF
Device class
Class 2
Regulation
21 CFR 870.1330
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Valley City, UT, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code MOF

view all

More clearances from Scientia Vascular, Inc.

view all

Adverse events under product code MOF

product code MOF
Death
6
Injury
137
Total
143

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.