Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire— 510(k) K253579
Substantially EquivalentScientia Vascular, Inc.
FDA 510(k) clearance K253579 for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire, Substantially Equivalent on 2026-04-29. Applicant: Scientia Vascular, Inc.. Device class: 2.
Summary
Scientia Vascular's record names four guidewires: the Aristotle 14, Aristotle 18, and Aristotle 24 Guidewires and the Zoom Wire 14 Guidewire. All four are filed under product code MOF (Guide, Wire, Catheter, Neurovasculature).
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 Vascular filed from West Valley City, Utah. The record shows 163 calendar days from receipt to decision (November 17, 2025 to April 29, 2026).
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
Recent devices under product code MOF
view allMore clearances from Scientia Vascular, Inc.
view allAdverse 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.