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
Sep 25, 2000
PERIPHERALLY INSERTED CENTRAL CATHETER
Utah Medical Products, Inc.
General Hospital
97d
Cleared
Sep 19, 2000
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
C.R. Bard, Inc.
General Hospital
89d
Cleared
Aug 03, 2000
VYGON 2 FR EPICUTANEO PUR-CATHETER
Vygon Corp.
General Hospital
325d
Cleared
Aug 03, 2000
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)
Vygon Corp.
General Hospital
296d
Cleared
Jan 18, 2000
FAS ENDOLUMINAL BRUSH
Fas Medical , Ltd.
General Hospital
85d
Cleared
Jan 13, 1999
VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)
Vygon Corp.
General Hospital
96d
Cleared
Dec 10, 1998
MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T
Medical Components, Inc.
General Hospital
73d
Cleared
Mar 24, 1998
ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
Luther Medical Products, Inc.
General Hospital
74d
Cleared
Dec 22, 1997
CATHETER TUNNELER
Gerard Medical, Inc.
General Hospital
168d
Cleared
Nov 24, 1997
PERIPHERALLY INSERTED CENTRAL
B.Braun Medical, Inc.
General Hospital
178d
Cleared
Nov 12, 1997
1.4 FR MAPCATH SENSOR STYLET
Navion Biomedical Corp.
General Hospital
89d
Cleared
Aug 01, 1997
DOUBLE LUMEN PICC
B.Braun Medical, Inc.
General Hospital
141d
Cleared
Jun 26, 1997
CLINICATH IR PERIPHERALLY INSERTED CATHETER
Sims Deltec, Inc.
General Hospital
154d
Cleared
Jun 02, 1997
PERIPHERALLY INSERTED CENTRAL CATHETER
B.Braun Medical, Inc.
General Hospital
175d
Cleared
Jun 02, 1997
SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER
B.Braun Medical, Inc.
General Hospital
69d
Cleared
Apr 16, 1997
PICC CATHETER/MIDLINE CATHETER
Menlo Care, Inc.
General Hospital
161d
Cleared
Apr 16, 1997
HR POLYURETHANE PICC AND MIDLINE CATHETERS
Johnson & Johnson Medical, Inc.
General Hospital
154d
Cleared
Apr 01, 1997
NEO-PICC
Klein-Baker Medical, Inc.
General Hospital
55d
Cleared
Mar 04, 1997
PERIPHERALLY INSERTED MEDLINE CATHETER
Arrow Intl., Inc.
General Hospital
197d
Cleared
Dec 12, 1996
CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)
Bmw Medical, Inc.
General Hospital
80d
Cleared
Nov 14, 1996
CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)
Bmw Medical, Inc.
General Hospital
90d
Cleared
Oct 18, 1996
CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)
Bmw Medical, Inc.
General Hospital
70d
Cleared
Oct 07, 1996
CATHETER INSERTION TRAY
Medcare Medical Group, Inc.
General Hospital
77d
Cleared
Sep 30, 1996
MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932
Pudenz-Schulte Medical Research Corp.
General Hospital
270d