Cleared Traditional

EmboCube Embolization Gelatin

K181021 · Biosphere Medical, S.A. · Cardiovascular
Sep 2018
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K181021 is an FDA 510(k) clearance for the EmboCube Embolization Gelatin, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Biosphere Medical, S.A. (Roissy-En-France, FR). The FDA issued a Cleared decision on September 27, 2018, 163 days after receiving the submission on April 17, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K181021 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2018
Decision Date September 27, 2018
Days to Decision 163 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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