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
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 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
May 15, 2013
3F PRO-PICC
Medical Components, Inc.
General Hospital
173d
Cleared
May 09, 2013
NMI PICC MAXIMAL BARRIER NURSING KITS
Navilyst Medical, Inc.
General Hospital
24d
Cleared
Dec 12, 2012
VASU-PICC
Medical Components, Inc.
General Hospital
125d
Cleared
Oct 18, 2012
NMI HPICC III
Navilyst Medical, Inc.
General Hospital
28d
Cleared
Aug 23, 2012
NMI PICC III
Navilyst Medical, Inc.
General Hospital
135d
Cleared
Aug 03, 2012
PICC CONVENIENCE KIT
Navilyst Medical, Inc.
General Hospital
28d
Cleared
Jun 06, 2012
MEDCOMP VASCU-PICC & MIDLINE CATHETERS
Medical Components, Inc.
General Hospital
57d
Cleared
May 02, 2012
1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC
Medical Components, Inc.
General Hospital
30d
Cleared
May 02, 2012
2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
Medical Components, Inc.
General Hospital
30d
Cleared
Mar 19, 2012
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
C.R. Bard, Inc.
General Hospital
87d
Cleared
Oct 20, 2011
SAPIENS TIP CONFIRMATION SYSTEM
C.R. Bard, Inc.
General Hospital
29d
Cleared
Jul 29, 2011
XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY
Navilyst Medical, Inc.
General Hospital
24d
Cleared
Jun 14, 2011
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
Cook, Inc.
General Hospital
42d
Cleared
Dec 21, 2010
2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC
Medcomp
General Hospital
77d
Cleared
Nov 17, 2010
POWERPICC SV CATHETERS
C.R. Bard, Inc.
General Hospital
107d
Cleared
Sep 02, 2010
NMI IC
Navilyst Medical, Inc.
General Hospital
114d
Cleared
Aug 27, 2010
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
Arrow Intl., Inc.
General Hospital
175d
Cleared
Mar 25, 2010
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
AngioDynamics, Inc.
General Hospital
143d