Cleared Traditional

MINAMO

K190176 · Asahi Intecc Co., Ltd. · Cardiovascular
Aug 2019
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K190176 is an FDA 510(k) clearance for the MINAMO, 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 August 1, 2019, 181 days after receiving the submission on February 1, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K190176 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2019
Decision Date August 01, 2019
Days to Decision 181 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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