Cleared Traditional

EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES

K141209 · Celonova Biosciences, Inc. · Cardiovascular

Aug 2014

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K141209 is an FDA 510(k) clearance for the EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Celonova Biosciences, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 7, 2014, 90 days after receiving the submission on May 9, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number	K141209 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2014
Decision Date	August 07, 2014
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF