Cleared Special

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire

K243938 · Scientia Vascular, Inc. · Neurology
Apr 2025
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K243938 is an FDA 510(k) clearance for the Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by Scientia Vascular, Inc. (West Valley City, US). The FDA issued a Cleared decision on April 1, 2025, 102 days after receiving the submission on December 20, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K243938 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2024
Decision Date April 01, 2025
Days to Decision 102 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MOF — Guide, Wire, Catheter, Neurovasculature
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330