FKQ · Class II · 21 CFR 876.5820

FDA Product Code FKQ: System, Dialysate Delivery, Central Multiple Patient

Leading manufacturers include Hospal Medical Corp., Travenol Laboratories, S.A. and Extracorporeal Medical Specialities, Inc..

61
Total
61
Cleared
81d
Avg days
1976
Since

FDA 510(k) Cleared System, Dialysate Delivery, Central Multiple Patient Devices (Product Code FKQ)

61 devices
1–24 of 61
Cleared Jul 24, 1989
TWO TANK DISSOLUTION MODULE
K893612
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 75d
Cleared Apr 27, 1988
MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
K874084
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 203d
Cleared Jun 09, 1987
ACTRIL FOR KIDNEY MACHINE DISINFECTANT
K861730
Renal Systems, Inc.
Gastroenterology & Urology · 399d
Cleared Jan 13, 1987
FOUR TANK DISSOLUTION MODULE
K864635
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 49d
Cleared Jul 10, 1986
MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445
K861472
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 79d
Cleared Jul 26, 1985
NATURALYTE BICARBONATE CONCENTRATE-DRY PACK
K852310
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Jan 22, 1985
NEPHROSS ALLEGRO H.F.
K844748
Organon Teknika Corp.
Gastroenterology & Urology · 47d
Cleared Jan 16, 1985
ST FAMILY OF HOLLOW FIBER DIALYZERS
K844756
Travenol Laboratories, S.A.
Gastroenterology & Urology · 42d
Cleared Jan 07, 1985
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
K843963
Renal Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Jul 31, 1984
PACKETS FOR THE PREP OF DIALYSATES &
K842154
Organon Teknika Corp.
Gastroenterology & Urology · 62d
Cleared May 22, 1984
CONCENTRATE CONDUCTIVITY METER
K841543
Renal Systems, Inc.
Gastroenterology & Urology · 36d
Cleared May 02, 1984
RENAPAK CONCENTRATE MIXING SYS.
K840182
Renal Systems, Inc.
Gastroenterology & Urology · 106d
Cleared Apr 02, 1984
BIOSPAL 3000S
K840811
Hospal Medical Corp.
Gastroenterology & Urology · 41d
Cleared Apr 02, 1984
BIOSPAL 2400S
K840812
Hospal Medical Corp.
Gastroenterology & Urology · 41d
Cleared Apr 02, 1984
BIOSPAL 1200S
K840813
Hospal Medical Corp.
Gastroenterology & Urology · 45d
Cleared Apr 02, 1984
HOSPAL MODEL H1210
K840814
Hospal Medical Corp.
Gastroenterology & Urology · 45d
Cleared Sep 12, 1983
GAMMA STERIL. CAPILLARY FLOW DIALY-G15
K832663
Travenol Laboratories, S.A.
Gastroenterology & Urology · 35d
Cleared Aug 08, 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K831940
Travenol Laboratories, S.A.
Gastroenterology & Urology · 53d
Cleared Jun 08, 1983
BICARBONATE/VARIABLE SODIUM KIT-DM-367
K830908
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 79d
Cleared Nov 22, 1982
HEMAFLO BLOOD TUBING SETS
K823092
Cobe Laboratories, Inc.
Gastroenterology & Urology · 33d
Cleared Oct 04, 1982
DISSCAP 080
K822851
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Sep 30, 1982
CIDEX*DIALYZER DISINFECTING SOLUTION
K822535
Surgikos, Inc.
Chemistry · 37d
Cleared Aug 30, 1982
HPF 100,200,300 CAPILLARY FLOW DIALYZ
K822485
Erika, Inc.
Gastroenterology & Urology · 13d
Cleared Apr 16, 1982
GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL
K820769
Gambro, Inc.
Gastroenterology & Urology · 25d

About Product Code FKQ - Regulatory Context