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
Oct 21, 2015
PICC Tip Positioning Aid
Nostix, LLC
General Hospital
71d
Cleared
Sep 24, 2015
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
Navilyst Medical, Inc.
General Hospital
29d
Cleared
Apr 24, 2015
C3 Wave
Medcomp ( Medical Components)
General Hospital
163d
Cleared
Mar 31, 2015
Xcela Power Injectable PICC
Navilyst Medical, Inc.
General Hospital
29d
Cleared
Mar 19, 2015
NMI PICC III and NMI PICC IV
Navilyst Medical, Inc.
General Hospital
27d
Cleared
Jan 27, 2015
NAUTILUS DELTA
Romedex International Srl
General Hospital
223d
Cleared
Jan 27, 2015
Celerity PICC Tip Confirmation System
AngioDynamics, Inc.
General Hospital
116d
Cleared
Oct 17, 2014
Sherlock 3CG Tip Positioning System Stylet
C.R. Bard, Inc.
General Hospital
63d
Cleared
Oct 14, 2014
PICC Maximal Barrier Nursing Kit
Navilyst Medical, Inc.
General Hospital
28d
Cleared
Sep 29, 2014
PRO-PICC WITH VALVE TECHNOLOGY
Medical Components, Inc.
General Hospital
103d
Cleared
Aug 05, 2014
TURBO-JECT PICC SETS
Cook Corporated
General Hospital
29d
Cleared
Jul 08, 2014
CT MIDLINE
Medcomp (Medical Components, Inc.)
General Hospital
64d
Cleared
Jun 13, 2014
CELERITY SYSYEM
Medcomp (Medical Components, Inc.)
General Hospital
74d
Cleared
Mar 14, 2014
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
C.R. Bard, Inc.
General Hospital
31d
Cleared
Mar 05, 2014
NMI PICC IV
Navilyst Medical, Inc.
General Hospital
30d
Cleared
Dec 23, 2013
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
Cook, Inc.
General Hospital
27d
Cleared
Nov 20, 2013
NMI PICC III
Navilyst Medical, Inc.
General Hospital
28d
Cleared
Nov 05, 2013
ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN
Covidien
General Hospital
82d
Cleared
Oct 22, 2013
MEDCOMP VASCU-PICC WITH VALVE
Medcomp ( Medical Components)
General Hospital
204d
Cleared
Oct 11, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
Cook Incorporated
General Hospital
25d
Cleared
Aug 16, 2013
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
Medical Components, Inc.
General Hospital
67d
Cleared
Aug 16, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
Cook, Inc.
General Hospital
21d
Cleared
Jul 31, 2013
NMI PICC III CATHETER, NMI HPICC III CATHETER
Navilyst Medical, Inc.
General Hospital
34d
Cleared
Jun 03, 2013
FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
Footprint Medical, Inc.
General Hospital
96d