Cleared Traditional

CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA

K062168 · Nemoto Kyorindo Co., Ltd. · Cardiovascular
Aug 2006
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K062168 is an FDA 510(k) clearance for the CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Nemoto Kyorindo Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on August 18, 2006, 18 days after receiving the submission on July 31, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K062168 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2006
Decision Date August 18, 2006
Days to Decision 18 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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