Cleared Special

SION blue PLUS

K243733 · Asahi Intecc Co., Ltd. · Cardiovascular
Apr 2025
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K243733 is an FDA 510(k) clearance for the SION blue PLUS, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Asahi Intecc Co., Ltd. (Seto-Shi, JP). The FDA issued a Cleared decision on April 2, 2025, 119 days after receiving the submission on December 4, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K243733 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2024
Decision Date April 02, 2025
Days to Decision 119 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

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