Cleared Special

EMBOGUARD Balloon Guide Catheter

K233924 · Neuravi Limited · Neurology

Apr 2024

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K233924 is an FDA 510(k) clearance for the EMBOGUARD Balloon Guide Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Neuravi Limited (Galway, IE). The FDA issued a Cleared decision on April 18, 2024, 127 days after receiving the submission on December 13, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K233924 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2023
Decision Date	April 18, 2024
Days to Decision	127 days
Submission Type	Special
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