CAK · Class II · 21 CFR 880.5440

FDA Product Code CAK: Microfilter, Blood Transfusion

Leading manufacturers include Pall Biomedical Products Co., Baxter Healthcare Corp and Abbott Laboratories.

36
Total
36
Cleared
62d
Avg days
1976
Since

FDA 510(k) Cleared Microfilter, Blood Transfusion Devices (Product Code CAK)

36 devices
1–24 of 36
Cleared May 17, 2006
HAEMONETICS 40U RBC FILTER BAG
K061103
Haemonetics Corp.
General Hospital · 27d
Cleared Oct 25, 2002
SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
K022477
Summit Medical , Ltd.
General Hospital · 88d
Cleared May 30, 2000
NEOCARE 20 MICRON BLOOD FILTER
K000719
Whatman, Inc.
General Hospital · 88d
Cleared Aug 30, 1999
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
K990310
Charter Medical, Ltd.
General Hospital · 210d
Cleared Sep 30, 1998
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
K982822
Baxter Healthcare Corp
General Hospital · 50d
Cleared Jul 23, 1997
FENWAL 40 MICRON TRANSFUSION FILTER
K972159
Baxter Healthcare Corp
General Hospital · 44d
Cleared Feb 14, 1997
ALPHA MICRON 20/40 MICROAGGREGATE FILTER
K970225
Alpha Therapeutic Corp.
General Hospital · 28d
Cleared Apr 22, 1996
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
K960993
Pall Biomedical Products Co.
General Hospital · 41d
Cleared Feb 12, 1996
ALPHA MICRON 20 MICROAGGREGATE FILTER
K955515
Alpha Therapeutic Corp.
General Hospital · 70d
Cleared Oct 26, 1990
SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS
K904221
Baxter Healthcare Corp
General Hospital · 43d
Cleared Oct 26, 1990
SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS
K904223
Baxter Healthcare Corp
General Hospital · 43d
Cleared Aug 08, 1990
MODIFIED SEPACELL R-SERIES BLOOD FILTERS
K901887
Asahi Medical Co., Ltd.
General Hospital · 104d
Cleared Feb 01, 1990
SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
K896203
Solco Basle, Inc.
General Hospital · 98d
Cleared Jan 24, 1990
MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
K896664
Asahi Medical Co., Ltd.
General Hospital · 61d
Cleared Jan 24, 1990
MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS
K896976
Asahi Medical Co., Ltd.
General Hospital · 42d
Cleared Jun 07, 1989
MICROSEPT 60/20
K890844
Arbor Technologies, Inc.
General Hospital · 106d
Cleared Jan 19, 1988
SEPACELL R-500 AND SEPACELL R-500A
K873792
Advocacy International, Ltd.
General Hospital · 124d
Cleared Jan 06, 1988
PALL LEUKOCYTE REMOVAL FILTER, BLOOD
K873666
Pall Biomedical Products Co.
General Hospital · 118d
Cleared Jan 06, 1988
PALL LEUKOCYTE REMOVAL FILTER, PLATELETS
K873667
Pall Biomedical Products Co.
General Hospital · 118d
Cleared Oct 22, 1987
RESUBMITTED MICRON TRANSFUSION FILTER
K873873
Travenol Laboratories, S.A.
General Hospital · 52d
Cleared Jan 14, 1987
ERYPUR B
K864636
Organon Teknika Corp.
General Hospital · 49d
Cleared Mar 12, 1986
SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE
K855064
Cobe Laboratories, Inc.
General Hospital · 84d
Cleared Jan 08, 1986
SEPACELL R-500 & SEPACELL R-500A
K854259
Advocacy International, Ltd.
General Hospital · 77d
Cleared Jun 27, 1985
INTERFACE TRANSFUSION BLOOD FILTER #35
K851370
Medical, Inc.
General Hospital · 83d

About Product Code CAK - Regulatory Context