Cleared Special

DUAL SHOT ALPHA 7

K133189 · Nemoto Kyorindo Co., Ltd. · Cardiovascular
Jun 2014
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K133189 is an FDA 510(k) clearance for the DUAL SHOT ALPHA 7, 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 June 30, 2014, 256 days after receiving the submission on October 17, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K133189 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2013
Decision Date June 30, 2014
Days to Decision 256 days
Submission Type Special
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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