Cleared Traditional

BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR

K073339 · Fenwal, Inc. · General Hospital

Mar 2008

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K073339 is an FDA 510(k) clearance for the BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR, a Set, Blood Transfusion (Class II — Special Controls, product code BRZ), submitted by Fenwal, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on March 3, 2008, 96 days after receiving the submission on November 28, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K073339 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2007
Decision Date	March 03, 2008
Days to Decision	96 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF