Cleared Traditional

Next Generation Access Catheter

K234074 · Balt USA, LLC · Neurology

Jul 2024

Decision

193d

Days

Class 2

Risk

About This 510(k) Submission

K234074 is an FDA 510(k) clearance for the Next Generation Access 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 July 2, 2024, 193 days after receiving the submission on December 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K234074 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2023
Decision Date	July 02, 2024
Days to Decision	193 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