Cleared Special

Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume

K173891 · Vascular Solutions, Inc. · Cardiovascular

Jan 2018

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K173891 is an FDA 510(k) clearance for the Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume, 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 January 19, 2018, 29 days after receiving the submission on December 21, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number	K173891 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2017
Decision Date	January 19, 2018
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF