Cleared Special

Gel-Bead

K171946 · Vascular Solutions, Inc. · Cardiovascular
Oct 2017
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K171946 is an FDA 510(k) clearance for the Gel-Bead, 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 October 25, 2017, 118 days after receiving the submission on June 29, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K171946 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2017
Decision Date October 25, 2017
Days to Decision 118 days
Submission Type Special
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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