FDA Product Code LJS: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Under FDA product code LJS, long-term implanted intravascular therapeutic catheters are cleared for extended vascular access over weeks to months.
These tunneled or implanted central venous catheters provide durable, reliable access to the central venous circulation for long-term chemotherapy, parenteral nutrition, hemodialysis, and repeated blood sampling without repeated peripheral venipuncture.
LJS devices are Class II medical devices, regulated under 21 CFR 880.5970 and reviewed by the FDA General Hospital panel.
Leading manufacturers include C.R. Bard, Inc., Navilyst Medical, Inc. and Medcomp.
302
Total
302
Cleared
131d
Avg days
1983
Since
302 devices
Cleared
Mar 07, 1994
3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH
Bard Access Systems, Inc.
General Hospital
446d
Cleared
Feb 07, 1994
RIGHT ATRIAL CATHETER
Akcess Medical Products, Inc.
General Hospital
364d
Cleared
Dec 30, 1993
STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM
Strato Medical Corp.
General Hospital
142d
Cleared
Dec 13, 1993
STRATO MEDICAL SINGLE LUMEN VALVED CATHETER
Strato Medical Corp.
General Hospital
441d
Cleared
Jul 30, 1993
STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH
Strato Medical Corp.
General Hospital
317d
Cleared
Jul 07, 1993
INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER
Strato Medical Corp.
General Hospital
450d
Cleared
Jun 07, 1993
L-CATH PEEL AWAY SYSTEM CATHETER
Luther Medical Products, Inc.
General Hospital
474d
Cleared
May 13, 1993
NEEDLELESS INJECTION CANNULA
Arrow Intl., Inc.
General Hospital
296d
Cleared
Oct 23, 1992
8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS
Davol, Inc.
General Hospital
193d
Cleared
Apr 19, 1991
8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER
Davol, Inc.
General Hospital
72d
Cleared
Mar 29, 1991
GESCO PER-Q-CATH REPAIR KIT
Gesco Intl., Inc.
General Hospital
45d
Cleared
Mar 07, 1991
VYGON LIFEVAC PICC
Vygon Corp.
General Hospital
206d
Cleared
Nov 05, 1990
PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT
Pharmacia Deltec, Inc.
General Hospital
45d
Cleared
Sep 21, 1990
WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER
Strato Medical Corp.
General Hospital
373d
Cleared
Apr 25, 1990
STRATO INDWELLING CATHETER
Strato Medical Corp.
General Hospital
155d
Cleared
Apr 23, 1990
EPICUTANEO-CAVA CATHETER CODE 2184
Vygon Corp.
General Hospital
117d
Cleared
Dec 15, 1989
PERCUTANEOUS INTRAVENOUS CATHETERS
Pharmacia Deltec, Inc.
General Hospital
81d
Cleared
Dec 05, 1989
DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS
Vas-Cath, Inc.
General Hospital
228d
Cleared
Aug 10, 1989
DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
107d
Cleared
Oct 04, 1988
PMT VASCULAR CATHETER MODEL NUMBER 3621-1
Pmt Corp.
General Hospital
60d
Cleared
Aug 09, 1988
MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
56d
Cleared
Apr 03, 1987
VAPOR-SEAL(TM) PERCUTANEOUS CATHETERS
Pharmacia, Inc.
General Hospital
165d
Cleared
Mar 14, 1986
GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
Cook, Inc.
General Hospital
381d
Cleared
Jun 07, 1985
VASCULAR ACCESS CATHETER
Sil-Med Corp.
General Hospital
73d