Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector

FDA 510(k) K073339 · Fenwal, Inc.

Substantially Equivalent

510(k) numberK073339

Submission

Device name
Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector
Applicant
Fenwal, Inc.
Lake Zurich, IL, US
Received
November 28, 2007
Decision date
March 3, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BRZ – Set, Blood Transfusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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Questions and answers

When was Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector cleared by the FDA?

Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector (K073339) received a 510(k) decision of Substantially Equivalent on March 3, 2008, 96 days after the submission was received.

What is the product code of K073339?

The FDA product code is BRZ – Set, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.