Cleared Special

ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE

K130307 · Celonova Biosciences, Inc. · Cardiovascular

Mar 2013

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K130307 is an FDA 510(k) clearance for the ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE, 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 March 4, 2013, 25 days after receiving the submission on February 7, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number	K130307 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2013
Decision Date	March 04, 2013
Days to Decision	25 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF