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 |