Cleared Special

Aristotle 18 Guidewire; Aristotle 24 Guidewire

K231954 · Scientia Vascular, Inc. · Neurology
Aug 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K231954 is an FDA 510(k) clearance for the Aristotle 18 Guidewire; Aristotle 24 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 August 1, 2023, 29 days after receiving the submission on July 3, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K231954 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2023
Decision Date August 01, 2023
Days to Decision 29 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