FDA 510(k) Applications for Medical Device Product Code "BRZ"
(Set, Blood Transfusion)

FDA 510(k) Number Applicant Device Name Decision Date
K132905 ARTERIOCYTE MEDICAL SYSTEMS, INC. 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER 10/04/2013
K993120 BAXTER HEALTHCARE CORP. MODIFIED BLOOD RECIPIENT SET 11/17/1999
K210335 Baxter Healthcare Corporation Blood Administration Set 06/10/2021
K220558 Baxter Healthcare Corporation Blood Administration Sets 11/17/2022
K050805 BLOOD PRODUCTS SPECIALTIES LLC 30 ML OR 60 ML PEDI-SYRINGE FILTER 06/20/2005
K050115 CARDINAL HEALTH, ALARIS PRODUCTS BLOOD HAND PUMP ADMINISTRATION SET 04/01/2005
K000685 CHARTER MEDICAL, LTD. CHARTER MEDICAL NEONATAL SYRINGE SET 08/15/2000
K073339 FENWAL, INC. BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR 03/03/2008
K972843 GLOBE ENT., INC. PROTOS BLOOD TRANSFUSION SET 12/16/1997
K041496 PENTAFERTE S.P.A PENTATRASFU BLOOD TRANSFUSION SETS 06/30/2005
K083349 SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS BLOOD TRANSFUSION SET 04/10/2009
K023039 TUTA HEALTHCARE PTY LIMITED BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 11/07/2002


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