Cleared Traditional

PRESS DUO elite, PRESS DUO elite AG

K173450 · Nemoto Kyorindo Co., Ltd. · Cardiovascular
Feb 2018
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K173450 is an FDA 510(k) clearance for the PRESS DUO elite, PRESS DUO elite AG, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Nemoto Kyorindo Co., Ltd. (Bunkyo-Ku, JP). The FDA issued a Cleared decision on February 7, 2018, 93 days after receiving the submission on November 6, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K173450 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2017
Decision Date February 07, 2018
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXT — Injector And Syringe, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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