Cleared Traditional

EmboCube Embolization Gelatin

K183120 · Biosphere Medical, S.A. · Cardiovascular
Aug 2019
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K183120 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 August 6, 2019, 270 days after receiving the submission on November 9, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K183120 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2018
Decision Date August 06, 2019
Days to Decision 270 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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