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

FDA 510(k) Number Applicant Device Name Decision Date
K830014 ABBOTT LABORATORIES HEMA - NV TRANS. BLOOD FILTER 100/800 01/17/1983
K812697 ABBOTT LABORATORIES HEMA 20 MICRON TRANSFUSION BLOOD FILTER 10/08/1981
K810855 ABBOTT LABORATORIES INTERFACE 20 MICRON TRANSFUSION BLD. F. 04/21/1981
K812874 ABBOTT LABORATORIES PEDIATRIC MICROAGGREGATE BLOOD FILTER 11/02/1981
K854259 ADVOCACY INTERNATIONAL, LTD. SEPACELL R-500 & SEPACELL R-500A 01/08/1986
K873792 ADVOCACY INTERNATIONAL, LTD. SEPACELL R-500 AND SEPACELL R-500A 01/19/1988
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
K810761 ALPHA THERAPEUTIC CORP. ALPHA MICRON-40 FILTER 06/30/1981
K890844 ARBOR TECHNOLOGIES, INC. MICROSEPT 60/20 06/07/1989
K896664 ASAHI MEDICAL CO., LTD. MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT 01/24/1990
K896976 ASAHI MEDICAL CO., LTD. MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS 01/24/1990
K901887 ASAHI MEDICAL CO., LTD. MODIFIED SEPACELL R-SERIES BLOOD FILTERS 08/08/1990
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
K904221 BAXTER HEALTHCARE CORP. SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS 10/26/1990
K904223 BAXTER HEALTHCARE CORP. SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS 10/26/1990
K760165 BENTLEY LABORATORIES, INC. FILTER, INFUSION BLOOD (1 PFF-100) 08/06/1976
K770253 BIOTEST-SERUM-INSTITUT MICROFILTRATION SET MF10 04/05/1977
K990310 CHARTER MEDICAL, LTD. CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) 08/30/1999
K855064 COBE LABORATORIES, INC. SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE 03/12/1986
K061103 HAEMONETICS CORP. HAEMONETICS 40U RBC FILTER BAG 05/17/2006
K823261 MEDICAL, INC. INTERFACE TRANSFUSION BLOOD FILTER #30 01/07/1983
K851370 MEDICAL, INC. INTERFACE TRANSFUSION BLOOD FILTER #35 06/27/1985
K864636 ORGANON TEKNIKA CORP. ERYPUR B 01/14/1987
K873666 PALL BIOMEDICAL PRODUCTS CO. PALL LEUKOCYTE REMOVAL FILTER, BLOOD 01/06/1988
K873667 PALL BIOMEDICAL PRODUCTS CO. PALL LEUKOCYTE REMOVAL FILTER, PLATELETS 01/06/1988
K960993 PALL BIOMEDICAL PRODUCTS CO. PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) 04/22/1996
K811985 PALL BIOMEDICAL PRODUCTS CO. ULTIPOR SQ40S BLOOD TRANSFUSION FILTER 07/28/1981
K896203 SOLCO BASLE, INC. SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER 02/01/1990
K780145 SORENSEN RESEARCH BLOOD FILTER, MICROEMBOLI-ATS-F10 02/02/1978
K022477 SUMMIT MEDICAL LTD. SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET 10/25/2002
K760222 SURGIKOS, INC. FILTER, TRANSFUSION BLOOD, INTERSEPT 08/06/1976
K830057 TRAVENOL LABORATORIES, S.A. 20 MICRON HIGH CAPACITY TRANS/FILTER 01/26/1983
K873873 TRAVENOL LABORATORIES, S.A. RESUBMITTED MICRON TRANSFUSION FILTER 10/22/1987
K000719 WHATMAN, INC. NEOCARE 20 MICRON BLOOD FILTER 05/30/2000


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