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
May 26, 2005
POWERHOHN AND POWERLINE CATHETERS
C.R. Bard, Inc.
General Hospital
119d
Cleared
Jan 14, 2005
6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
C.R. Bard, Inc.
General Hospital
25d
Cleared
Dec 10, 2004
KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304
Kendall
General Hospital
91d
Cleared
Nov 22, 2004
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER
Becton, Dickinson & CO
General Hospital
69d
Cleared
Nov 01, 2004
TRIFUSION, MODEL 0609190/0659350
C.R. Bard, Inc.
General Hospital
189d
Cleared
Sep 09, 2004
PREMICATH, 1261.205
Vygon Corp.
General Hospital
99d
Cleared
Aug 27, 2004
PICC
Arrow Intl., Inc.
General Hospital
21d
Cleared
Jul 26, 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
AngioDynamics, Inc.
General Hospital
59d
Cleared
Mar 19, 2004
POWERPICC CATHETERS, MODELS 3175155, 3175135
C.R. Bard, Inc.
General Hospital
148d
Cleared
Mar 05, 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
AngioDynamics, Inc.
General Hospital
14d
Cleared
Jan 21, 2004
POLY PER-Q-CATH PICC CATHETERS
C.R. Bard, Inc.
General Hospital
28d
Cleared
Jan 21, 2004
GROSHONG NXT PICC CATHETERS
C.R. Bard, Inc.
General Hospital
28d
Cleared
Jul 02, 2003
LIFEVALVE CENTRAL VENOUS CATHTER
Horizon Medical Products, Inc.
General Hospital
29d
Cleared
Jun 19, 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
AngioDynamics, Inc.
General Hospital
23d
Cleared
May 05, 2003
POLY PER-Q-CATH PICC CATHETERS
C.R. Bard, Inc.
General Hospital
26d
Cleared
Apr 30, 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
AngioDynamics, Inc.
General Hospital
82d
Cleared
Apr 11, 2003
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON
Medcomp
General Hospital
74d
Cleared
Feb 07, 2003
SILICONE DUAL LUMEN RADPICC CATHETERS
C.R. Bard, Inc.
General Hospital
14d
Cleared
Dec 18, 2002
GROSHONG NXT DUAL LUMEN PICC CATHETERS
C.R. Bard, Inc.
General Hospital
71d
Cleared
Sep 10, 2001
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
C.R. Bard, Inc.
General Hospital
12d
Cleared
Aug 01, 2001
CENTRAL VENOUS CATHETER
Boston Scientific Corp
General Hospital
232d
Cleared
Jan 26, 2001
MEDCOMP Z-CATH
Medical Components, Inc.
General Hospital
57d
Cleared
Dec 29, 2000
SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20
Plastimed Laboratoire Pharmaceutique
General Hospital
527d
Cleared
Dec 01, 2000
MEDCOMP BIO-CATH CATHETER LINE
Medcomp
General Hospital
58d