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
Jun 18, 2018
Sherlock 3CG+ T ip Confirmation System
C.R. Bard, Inc.
General Hospital
109d
Cleared
May 21, 2018
Biowy PlCC Catheter
Biowy Corporation
General Hospital
144d
Cleared
Apr 26, 2018
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers
C.R. Bard, Inc (Bard Has Joined Bd)
General Hospital
56d
Cleared
Apr 20, 2018
Hickman TriFusion Catheter
C.R. Bard, Inc.
General Hospital
242d
Cleared
Apr 12, 2018
C3 Wave System
Medical Components, Inc. (dba MedComp)
General Hospital
38d
Cleared
Feb 26, 2018
Vygon PICCs
Vygon USA
General Hospital
157d
Cleared
Feb 22, 2018
Silicone Peripherally Inserted Central Venous Catheter Set/Tray
Cook Incorporated
General Hospital
234d
Cleared
Feb 20, 2018
HydroPICC
Access Vascular, Inc.
General Hospital
152d
Cleared
Sep 29, 2017
Sherlock 3CG Tip Positioning System Stylet
C.R. Bard, Inc.
General Hospital
52d
Cleared
Apr 24, 2017
PowerPICC Provena Catheters with SOLO Valve Technology
C.R. Bard, Inc.
General Hospital
236d
Cleared
Feb 03, 2017
PICC Maximal Barrier Nursing Kit
Navilyst Medical, Inc.
General Hospital
56d
Cleared
Oct 25, 2016
PowerPICC Provena Catheters
C.R. Bard, Inc.
General Hospital
55d
Cleared
Oct 07, 2016
Turbo-Flo PICC Sets
Cook Incorporated
General Hospital
128d
Cleared
Jun 14, 2016
PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
C.R. Bard, Inc.
General Hospital
333d
Cleared
Sep 24, 2015
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
Navilyst Medical, Inc.
General Hospital
29d
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
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
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