Cleared Traditional

CHIKAI Nexus 014

K243383 · Asahi Intecc Co., Ltd. · Neurology
Apr 2025
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K243383 is an FDA 510(k) clearance for the CHIKAI Nexus 014, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by Asahi Intecc Co., Ltd. (Seto-Shi, JP). The FDA issued a Cleared decision on April 21, 2025, 172 days after receiving the submission on October 31, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K243383 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2024
Decision Date April 21, 2025
Days to Decision 172 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MOF — Guide, Wire, Catheter, Neurovasculature
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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