Cleared Special

ASAHI Neurovascular Guide Wire CHIKAI X 014 soft

K191714 · Asahi Intecc Co., Ltd. · Neurology
Jul 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K191714 is an FDA 510(k) clearance for the ASAHI Neurovascular Guide Wire CHIKAI X 014 soft, 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 July 26, 2019, 30 days after receiving the submission on June 26, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K191714 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2019
Decision Date July 26, 2019
Days to Decision 30 days
Submission Type Special
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