Cleared Traditional

Socrates Aspiration System

K223913 · Scientia Vascular, Inc. · Neurology

Sep 2023

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K223913 is an FDA 510(k) clearance for the Socrates Aspiration System, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Scientia Vascular, Inc. (West Valley City, US). The FDA issued a Cleared decision on September 20, 2023, 265 days after receiving the submission on December 29, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K223913 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2022
Decision Date	September 20, 2023
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NRY — Catheter, Thrombus Retriever
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.