Cleared Traditional

Embosphere Microspheres

K181300 · Biosphere Medical, S.A. · Neurology
Jul 2018
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K181300 is an FDA 510(k) clearance for the Embosphere Microspheres, 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 July 16, 2018, 60 days after receiving the submission on May 17, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K181300 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2018
Decision Date July 16, 2018
Days to Decision 60 days
Submission Type Traditional
Review Panel Neurology (NE)
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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