Aristotle Mini Guidewire— 510(k) K260223

Name: FDA 510(k) clearance K260223
Creator: U.S. Food and Drug Administration
Published: 2026-08-06

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.

Clearance details

Applicant: Scientia Vascular, Inc.
Product code: Code MOF
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2026-01-26
Decision date: 2026-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Valley City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOF

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K260751 — 35 Helix Guidewire2026-08-27
K262424 — Willow 12 Guidewire2026-08-14
K254006 — Drivewire 35 Guidewire2026-07-17
K253579 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire2026-04-29
K252317 — Zenith Micro Guidewire2026-04-16

More clearances from Scientia Vascular, Inc.

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K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter)2026-07-16
K243938 — Aristotle 14 Guidewire +4 more2025-04-01
K242301 — Socrates 38 Catheter2024-12-04
K223913 — Socrates Aspiration System2023-09-20
K223560 — Plato 17 Microcatheter2023-08-21

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.