FDA 510(k) Applications for Medical Device Product Code "CAK"
(Microfilter, Blood Transfusion)

FDA 510(k) Number Applicant Device Name Decision Date
K955515 ALPHA THERAPEUTIC CORP. ALPHA MICRON 20 MICROAGGREGATE FILTER 02/12/1996
K970225 ALPHA THERAPEUTIC CORP. ALPHA MICRON 20/40 MICROAGGREGATE FILTER 02/14/1997
K982822 BAXTER HEALTHCARE CORP. FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 09/30/1998
K972159 BAXTER HEALTHCARE CORP. FENWAL 40 MICRON TRANSFUSION FILTER 07/23/1997
K990310 CHARTER MEDICAL, LTD. CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) 08/30/1999
K061103 HAEMONETICS CORP. HAEMONETICS 40U RBC FILTER BAG 05/17/2006
K960993 PALL BIOMEDICAL PRODUCTS CO. PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) 04/22/1996
K022477 SUMMIT MEDICAL LTD. SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET 10/25/2002
K000719 WHATMAN, INC. NEOCARE 20 MICRON BLOOD FILTER 05/30/2000


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