Cleared Traditional

SOFIA EX Intracranial Support Catheter

K230775 · MicroVention, Inc. · Neurology

Sep 2023

Decision

177d

Days

Class 2

Risk

About This 510(k) Submission

K230775 is an FDA 510(k) clearance for the SOFIA EX Intracranial Support Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by MicroVention, Inc. (Aliso Veijo, US). The FDA issued a Cleared decision on September 14, 2023, 177 days after receiving the submission on March 21, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K230775 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2023
Decision Date	September 14, 2023
Days to Decision	177 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