Cleared Traditional

Embosphere Microspheres

K250971 · Biosphere Medical, S.A. · Cardiovascular
May 2025
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K250971 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 May 16, 2025, 46 days after receiving the submission on March 31, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K250971 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2025
Decision Date May 16, 2025
Days to Decision 46 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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