Cleared Traditional

200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER

K132905 · Arteriocyte Medical Systems, Inc. · General Hospital

Oct 2013

Decision

18d

Days

Class 2

Risk

About This 510(k) Submission

K132905 is an FDA 510(k) clearance for the 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER, a Set, Blood Transfusion (Class II — Special Controls, product code BRZ), submitted by Arteriocyte Medical Systems, Inc. (Hopkinton, US). The FDA issued a Cleared decision on October 4, 2013, 18 days after receiving the submission on September 16, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K132905 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2013
Decision Date	October 04, 2013
Days to Decision	18 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF