Cleared Traditional

GEL-BEAD EMBOLIZATION SPHERES

K133237 · Vascular Solutions, Inc. · Cardiovascular
Apr 2014
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K133237 is an FDA 510(k) clearance for the GEL-BEAD EMBOLIZATION SPHERES, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on April 25, 2014, 186 days after receiving the submission on October 21, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K133237 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2013
Decision Date April 25, 2014
Days to Decision 186 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRD — Device, Vascular, For Promoting Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3300

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