Cleared Traditional

CHIKAI Nexus petit

K252011 · Asahi Intecc Co., Ltd. · Neurology
Feb 2026
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K252011 is an FDA 510(k) clearance for the CHIKAI Nexus petit, 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 February 2, 2026, 220 days after receiving the submission on June 27, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K252011 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2025
Decision Date February 02, 2026
Days to Decision 220 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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