FDA 510(k) Applications for Medical Device Product Code "LFJ"
(Catheter, Subclavian)

FDA 510(k) Number Applicant Device Name Decision Date
K823135 ABBOTT LABORATORIES DOUBLE LUMEN SUBCLAVIAN CATHETER 03/07/1983
K925818 AKCESS MEDICAL PRODUCTS, INC. AKCESS-CATH 04/05/1994
K914826 AKCESS MEDICAL PRODUCTS, INC. AKCESS-CATH KIT 04/10/1992
K925819 AKCESS MEDICAL PRODUCTS, INC. AKCESS0CATH KIT 08/02/1994
K931120 AKCESS MEDICAL PRODUCTS, INC. COAXIAL ACUTE CATHETER 01/14/1994
K891755 AKCESS MEDICAL PRODUCTS, INC. DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K 06/08/1989
K891753 AKCESS MEDICAL PRODUCTS, INC. DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800 06/08/1989
K900803 AKCESS MEDICAL PRODUCTS, INC. DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S 04/25/1990
K910501 AKCESS MEDICAL PRODUCTS, INC. PERMANENT SILICONE CATHETERS 04/29/1991
K904139 AKCESS MEDICAL PRODUCTS, INC. SINGLE LUMEN CATHETER KITS 12/04/1990
K904140 AKCESS MEDICAL PRODUCTS, INC. SINGLE LUMEN CATHETERS, MODIFICATION 11/27/1990
K920634 AKCESS MEDICAL PRODUCTS, INC. SPLITTABLE SHEATH INTRODUCER SET 01/14/1994
K901061 AKCESS MEDICAL PRODUCTS, INC. SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000 05/22/1990
K895417 ARROW INTL., INC. ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT 01/03/1990
K884322 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SUBCLAVIAN HEMODIALYSIS CATHETER 04/25/1989
K820238 COBE LABORATORIES, INC. COBE ACUFLEX SSN, #15-220 03/10/1982
K913468 COOK, INC. ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY 03/24/1994
K881695 DESERET MEDICAL, INC. DESERET SUBCLAVIAN HEMODIALYSIS CATHETER 06/23/1988
K860094 GISH BIOMEDICAL, INC. HURWITZ DIALYSIS CATHETER 04/07/1986
K821012 HOLTER-HAUSNER INTL. H-H ALIMENTATION CATHETERS 05/28/1982
K901133 IMPRA, INC. DURACATH 06/08/1990
K883592 IMPRA, INC. IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER 12/08/1988
K905080 KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER 01/31/1991
K830438 MED COMP MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM 03/17/1983
K821955 MED COMP MCSCK638 CATHETER IN A TRAY (KIT) 07/14/1982
K821954 MED COMP MCSCK838 CATHETER IN A TRAY (KIT) 07/14/1982
K852162 MED-WEST, INC. MNI 400 INJECTION CAPS 06/12/1985
K915423 MEDICAL COMPONENTS, INC. HEMO-CATH SILICONE ACCESS CATHETER 02/02/1993
K893439 MEDICAL COMPONENTS, INC. HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C 06/13/1989
K890029 MEDICAL COMPONENTS, INC. HEMO-CATH SILICONE DOUBLE LUMEN CATHETER 04/17/1989
K821684 MEDICAL COMPONENTS, INC. MCSCP8PS WITH 'Y' HUB 06/24/1982
K801672 MEDICAL COMPONENTS, INC. MEDCOMP SUBCLAVIAN CATHETER 12/18/1980
K880778 MEDSURG INDUSTRIES, INC. MEDSURG ACUTE DIALYSIS TRAY 07/15/1988
K920780 MEDSURG INDUSTRIES, INC. MEDSURG INSERTION TRAY 08/19/1994
K871749 QUINTON, INC. ADULT PERM-CATH 40CM. 06/17/1987
K821400 QUINTON, INC. MAHURKAR SUBCLAVIAN CATHETER 06/23/1982
K900835 QUINTON, INC. MODIFIED PERM-CATH 05/09/1990
K871942 QUINTON, INC. PERM-CATH CATHETER KIT 06/17/1987
K874633 QUINTON, INC. PERMCATH INSERTION TRAY 02/17/1988
K822910 QUINTON, INC. RIGHT ARTERIAL CATHETER 11/29/1982
K822964 QUINTON, INC. RIGHT ATRIAL CATHETER 11/30/1982
K870328 QUINTON, INC. SINGLE LUMEN ACUTE CATHETER 05/11/1987
K821001 RENAL SYSTEMS, INC. MCPARLAND SCALP VEIN CATHETER 07/22/1982
K833848 SHILEY, INC. DUAL LUMEN SUBCLAVIAN CANNULA 12/08/1983
K881290 SHILEY, INC. MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA 04/27/1988
K863697 SHILEY, INC. MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA 10/02/1986
K822134 SHILEY, INC. SHIELY DUEL LUMEN SUBCLAVIAN CANNULA 08/03/1982
K861174 SHILEY, INC. SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA 04/23/1986
K852070 SHILEY, INC. SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL 06/13/1985
K840197 SHILEY, INC. SINGLE LUMEN SUBCLAVIAN CANNULA 04/25/1984
K812326 SORENSEN RESEARCH SORENSON SUBCLAVIAN CATHETER SSC-8 09/25/1981
K810745 VAS-CATH OF CANADA LTD. DOUBLE LUMEN SUBCLAVIN CATHETER SC-400 03/31/1981
K875188 VAS-CATH OF CANADA LTD. LUER LOCK CONNECTORS / RIDIG P.V.C. 03/02/1988
K844433 VAS-CATH OF CANADA LTD. VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA 03/13/1985
K844434 VAS-CATH OF CANADA LTD. VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH 03/13/1985
K853283 VAS-CATH OF CANADA LTD. VACCESS TM 4006 08/22/1985
K844336 VAS-CATH OF CANADA LTD. VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH 03/13/1985
K871488 VAS-CATH OF CANADA LTD. VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH 06/12/1987
K871487 VAS-CATH OF CANADA LTD. VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH 06/12/1987
K895506 VAS-CATH, INC. FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER 02/09/1990
K890099 VAS-CATH, INC. MODIFIED VAS-CATH CATHETER REPAIR KIT 04/11/1989
K883768 VAS-CATH, INC. VAS-CATH CATHETER REPAIR KIT 11/14/1988
K914162 VAS-CATH, INC. VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS 07/01/1993
K881743 VAS-CATH, INC. VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER 06/23/1988
K896568 VYGON CORP. "DUALYSE-CATH" - CODES #1132.212, 1132.112 05/09/1990


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact