Cleared Traditional

Next Generation Access Platform

K242376 · Balt USA, LLC · Neurology

Dec 2024

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K242376 is an FDA 510(k) clearance for the Next Generation Access Platform, 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 December 30, 2024, 143 days after receiving the submission on August 9, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K242376 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2024
Decision Date	December 30, 2024
Days to Decision	143 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