Cleared Traditional

Torpedo Gelatin Foam

K183578 · Biosphere Medical, S.A. · Cardiovascular
Jun 2019
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K183578 is an FDA 510(k) clearance for the Torpedo Gelatin Foam, 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 June 18, 2019, 179 days after receiving the submission on December 21, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K183578 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2018
Decision Date June 18, 2019
Days to Decision 179 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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