Cleared Special

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit

K182276 · Bayer Medical Care, Inc. · Cardiovascular
Nov 2018
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K182276 is an FDA 510(k) clearance for the MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Bayer Medical Care, Inc. (Indianola, US). The FDA issued a Cleared decision on November 1, 2018, 71 days after receiving the submission on August 22, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K182276 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2018
Decision Date November 01, 2018
Days to Decision 71 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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