Cleared Special

Gel-Block 10X embolization pledgets

K143038 · Vascular Solutions, Inc. · Cardiovascular
Nov 2014
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K143038 is an FDA 510(k) clearance for the Gel-Block 10X embolization pledgets, 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 November 20, 2014, 29 days after receiving the submission on October 22, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K143038 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2014
Decision Date November 20, 2014
Days to Decision 29 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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