Cleared Traditional

REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS

K092896 · Nemoto Kyorindo Co., Ltd. · Cardiovascular
Oct 2010
Decision
403d
Days
Class 2
Risk

About This 510(k) Submission

K092896 is an FDA 510(k) clearance for the REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Nemoto Kyorindo Co., Ltd. (Kawaguchi-Shi, Saitama, JP). The FDA issued a Cleared decision on October 29, 2010, 403 days after receiving the submission on September 21, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K092896 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2009
Decision Date October 29, 2010
Days to Decision 403 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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