Cleared Traditional

MR Syringe Dual Pack for Solaris Injectors

K161471 · Coeur, Inc. · Cardiovascular
Oct 2016
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K161471 is an FDA 510(k) clearance for the MR Syringe Dual Pack for Solaris Injectors, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on October 6, 2016, 132 days after receiving the submission on May 27, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K161471 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2016
Decision Date October 06, 2016
Days to Decision 132 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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