Cleared Traditional

FUBUKI XF Neurovascular Long Sheath

K213589 · Asahi Intecc Co., Ltd. · Neurology

Mar 2022

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K213589 is an FDA 510(k) clearance for the FUBUKI XF 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 March 24, 2022, 132 days after receiving the submission on November 12, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K213589 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2021
Decision Date	March 24, 2022
Days to Decision	132 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