Cleared Traditional

MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY

K063090 · Medrad, Inc. · Cardiovascular
Mar 2007
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K063090 is an FDA 510(k) clearance for the MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY, a Injector, Contrast Medium, Automatic (Class II — Special Controls, product code IZQ), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on March 27, 2007, 168 days after receiving the submission on October 10, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K063090 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2006
Decision Date March 27, 2007
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code IZQ — Injector, Contrast Medium, Automatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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