CAK · Class II · 21 CFR 880.5440

FDA Product Code CAK: Microfilter, Blood Transfusion

Leading manufacturers include Abbott Laboratories, Baxter Healthcare Corp and Travenol Laboratories, S.A..

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 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 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 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 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 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 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
Cleared Aug 06, 1976
FILTER, TRANSFUSION BLOOD, INTERSEPT
K760222
Surgikos, Inc.
General Hospital · 25d

About Product Code CAK - Regulatory Context