Cleared Traditional

DUAL SHOT - CONTRAST DELIVERY SYSTEM

K052633 · Nemoto Kyorindo Co., Ltd. · Cardiovascular
Oct 2005
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K052633 is an FDA 510(k) clearance for the DUAL SHOT - CONTRAST DELIVERY SYSTEM, 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 October 17, 2005, 21 days after receiving the submission on September 26, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K052633 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2005
Decision Date October 17, 2005
Days to Decision 21 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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