Cleared Traditional

Aristotle Colossus Guidewire

K222437 · Scientia Vascular, Inc. · Neurology
Jan 2023
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K222437 is an FDA 510(k) clearance for the 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 January 26, 2023, 167 days after receiving the submission on August 12, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K222437 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2022
Decision Date January 26, 2023
Days to Decision 167 days
Submission Type Traditional
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