Cleared Special

FUBUKI XF-R Neurovascular Long Sheath

K251560 · Asahi Intecc Co., Ltd. · Neurology

Jun 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K251560 is an FDA 510(k) clearance for the FUBUKI XF-R Neurovascular Long Sheath, 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, 30 days after receiving the submission on May 21, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K251560 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2025
Decision Date	June 20, 2025
Days to Decision	30 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