Cleared Traditional

NG Delivery Catheter

K230609 · Balt USA, LLC · Neurology

Sep 2023

Decision

191d

Days

Class 2

Risk

About This 510(k) Submission

K230609 is an FDA 510(k) clearance for the NG Delivery Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on September 13, 2023, 191 days after receiving the submission on March 6, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K230609 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2023
Decision Date	September 13, 2023
Days to Decision	191 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