Cleared Traditional

K253579 - Aristotle 14 Guidewire (FDA 510(k) Clearance)

Also includes:
Aristotle 18 Guidewire Aristotle 24 Guidewire Zoom Wire 14 Guidewire

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253579 · Scientia Vascular, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
163d
Days
Class 2
Risk

K253579 is an FDA 510(k) clearance for the Aristotle 14 Guidewire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Scientia Vascular, Inc. (West Valley City, US). The FDA issued a Cleared decision on April 29, 2026 after a review of 163 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Scientia Vascular, Inc. devices

Submission Details

510(k) Number K253579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date April 29, 2026
Days to Decision 163 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 148d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOF Guide, Wire, Catheter, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - MOF Guide, Wire, Catheter, Neurovasculature

All 39
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