CAK · Class II · 21 CFR 880.5440

FDA Product Code CAK: Microfilter, Blood Transfusion

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

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 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 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 Jun 27, 1985
INTERFACE TRANSFUSION BLOOD FILTER #35
K851370
Medical, Inc.
General Hospital · 83d
Cleared Jan 26, 1983
20 MICRON HIGH CAPACITY TRANS/FILTER
K830057
Travenol Laboratories, S.A.
General Hospital · 19d
Cleared Jan 17, 1983
HEMA - NV TRANS. BLOOD FILTER 100/800
K830014
Abbott Laboratories
General Hospital · 14d
Cleared Jan 07, 1983
INTERFACE TRANSFUSION BLOOD FILTER #30
K823261
Medical, Inc.
General Hospital · 66d
Cleared Nov 02, 1981
PEDIATRIC MICROAGGREGATE BLOOD FILTER
K812874
Abbott Laboratories
General Hospital · 19d
Cleared Oct 08, 1981
HEMA 20 MICRON TRANSFUSION BLOOD FILTER
K812697
Abbott Laboratories
General Hospital · 16d
Cleared Jul 28, 1981
ULTIPOR SQ40S BLOOD TRANSFUSION FILTER
K811985
Pall Biomedical Products Co.
Hematology · 15d
Cleared Apr 21, 1981
INTERFACE 20 MICRON TRANSFUSION BLD. F.
K810855
Abbott Laboratories
Hematology · 22d
Cleared Feb 02, 1978
BLOOD FILTER, MICROEMBOLI-ATS-F10
K780145
Sorensen Research
General Hospital · 3d
Cleared Aug 06, 1976
FILTER, INFUSION BLOOD (1 PFF-100)
K760165
Bentley Laboratories, Inc.
General Hospital · 31d

About Product Code CAK - Regulatory Context