Cleared Traditional

Socrates 38 Catheter

K242301 · Scientia Vascular, Inc. · Neurology

Dec 2024

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K242301 is an FDA 510(k) clearance for the Socrates 38 Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Scientia Vascular, Inc. (West Valley City, US). The FDA issued a Cleared decision on December 4, 2024, 124 days after receiving the submission on August 2, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K242301 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2024
Decision Date	December 04, 2024
Days to Decision	124 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QJP — Catheter, Percutaneous, Neurovasculature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures