Cleared Traditional

Branchor X Balloon Guide Catheter

K251240 · Asahi Intecc Co., Ltd. · Neurology

Jun 2025

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K251240 is an FDA 510(k) clearance for the Branchor X Balloon Guide Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Asahi Intecc Co., Ltd. (Seto-Shi, JP). The FDA issued a Cleared decision on June 20, 2025, 59 days after receiving the submission on April 22, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K251240 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2025
Decision Date	June 20, 2025
Days to Decision	59 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