LJS · Class II · 21 CFR 880.5970

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
241–264 of 302
Cleared Apr 17, 1985
ARROW-GEISS PERCUTANEOUS TPN KIT
K844080
Arrow Intl., Inc.
General Hospital · 180d
Cleared Nov 15, 1984
ARGYLE SILICONE CENTRAL VENOUS CATH-
K843450
Sherwood Medical Co.
General Hospital · 71d
Cleared Jul 13, 1984
RIGHT ATRIAL CATHETER
K840742
The Healthcare Group Laboratories, Inc.
General Hospital · 161d
Cleared Jul 13, 1984
SHEATH REMOVER
K841878
Datascope Corp.
General Hospital · 67d
Cleared May 01, 1984
LONG TERM CENTRAL VENOUS ACCESS CATH
K834299
Burron Medical Products, Inc.
General Hospital · 145d
Cleared May 01, 1984
DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT
K834383
Burron Medical Products, Inc.
General Hospital · 139d
Cleared Apr 30, 1984
MULTI-LUMEN CENTRAL VENOUS CATH. KIT
K834473
Burron Medical Products, Inc.
General Hospital · 132d
Cleared Apr 17, 1984
DESERET LONG TERM INDWELLING CATHETER
K840958
Parke-Davis Co.
General Hospital · 42d
Cleared Mar 19, 1984
PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM
K833442
Quinton, Inc.
General Hospital · 166d
Cleared Mar 06, 1984
SILCATH
K834091
Hdc Corp.
General Hospital · 99d
Cleared Feb 13, 1984
RAAF DUAL LUMEN CATH. REPAIR KIT 2.2
K834225
Quinton, Inc.
General Hospital · 69d
Cleared Jan 11, 1984
LIFE VAC #2191 & 2192
K831802
Exco, Inc.
General Hospital · 222d
Cleared Jan 03, 1984
RAAF CATHETER REPAIR KIT
K832580
Quinton, Inc.
General Hospital · 154d
Cleared Jan 03, 1984
REPAIR KITS FOR RIGHT ATRIAL CATH
K832774
Quinton, Inc.
General Hospital · 140d
Cleared Oct 19, 1983
TEMP. REPAIR KIT-DUAL LUMEN CATHETER
K831587
Norton Performance Plastics Corp.
General Hospital · 155d
Cleared Aug 24, 1983
PER-Q-CATH TRAY
K831845
Gesco Intl., Inc.
General Hospital · 77d
Cleared Apr 14, 1983
PERM. REPAIR KIT FOR LEONARD NORTON DUAL
K830969
Norton Performance Plastics Corp.
General Hospital · 17d