Cleared Special

Carrier XL Delivery Catheter

K252569 · Balt USA, LLC · Neurology

Oct 2025

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K252569 is an FDA 510(k) clearance for the Carrier XL 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 October 22, 2025, 69 days after receiving the submission on August 14, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K252569 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2025
Decision Date	October 22, 2025
Days to Decision	69 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