Cleared Traditional

MINAMO blue; MINAMO viola

K240387 · Asahi Intecc Co., Ltd. · Cardiovascular
Jun 2024
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K240387 is an FDA 510(k) clearance for the MINAMO blue; MINAMO viola, 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 June 21, 2024, 134 days after receiving the submission on February 8, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K240387 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2024
Decision Date June 21, 2024
Days to Decision 134 days
Submission Type Traditional
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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