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
Apr 17, 1985
ARROW-GEISS PERCUTANEOUS TPN KIT
Arrow Intl., Inc.
General Hospital
180d
Cleared
Nov 15, 1984
ARGYLE SILICONE CENTRAL VENOUS CATH-
Sherwood Medical Co.
General Hospital
71d
Cleared
Jul 13, 1984
RIGHT ATRIAL CATHETER
The Healthcare Group Laboratories, Inc.
General Hospital
161d
Cleared
Jul 13, 1984
SHEATH REMOVER
Datascope Corp.
General Hospital
67d
Cleared
May 01, 1984
LONG TERM CENTRAL VENOUS ACCESS CATH
Burron Medical Products, Inc.
General Hospital
145d
Cleared
May 01, 1984
DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT
Burron Medical Products, Inc.
General Hospital
139d
Cleared
Apr 30, 1984
MULTI-LUMEN CENTRAL VENOUS CATH. KIT
Burron Medical Products, Inc.
General Hospital
132d
Cleared
Apr 17, 1984
DESERET LONG TERM INDWELLING CATHETER
Parke-Davis Co.
General Hospital
42d
Cleared
Mar 19, 1984
PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM
Quinton, Inc.
General Hospital
166d
Cleared
Mar 06, 1984
SILCATH
Hdc Corp.
General Hospital
99d
Cleared
Feb 13, 1984
RAAF DUAL LUMEN CATH. REPAIR KIT 2.2
Quinton, Inc.
General Hospital
69d
Cleared
Jan 11, 1984
LIFE VAC #2191 & 2192
Exco, Inc.
General Hospital
222d
Cleared
Jan 03, 1984
RAAF CATHETER REPAIR KIT
Quinton, Inc.
General Hospital
154d
Cleared
Jan 03, 1984
REPAIR KITS FOR RIGHT ATRIAL CATH
Quinton, Inc.
General Hospital
140d
Cleared
Oct 19, 1983
TEMP. REPAIR KIT-DUAL LUMEN CATHETER
Norton Performance Plastics Corp.
General Hospital
155d
Cleared
Aug 24, 1983
PER-Q-CATH TRAY
Gesco Intl., Inc.
General Hospital
77d
Cleared
Apr 14, 1983
PERM. REPAIR KIT FOR LEONARD NORTON DUAL
Norton Performance Plastics Corp.
General Hospital
17d