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
Dec 06, 2017
C3 Wave System
Medical Components, Inc. (dba MedComp)
General Hospital
251d
Cleared
Oct 26, 2017
Celerity ECG Cable Accessory Pack
Medcomp (Medical Components, Inc.)
General Hospital
120d
Cleared
Sep 29, 2017
Sherlock 3CG Tip Positioning System Stylet
C.R. Bard, Inc.
General Hospital
52d
Cleared
Aug 03, 2017
CATHTONG II PICC Catheter
L&Z Us, Inc.
General Hospital
29d
Cleared
May 25, 2017
CATHTONG II PICC Catheter
L&Z Us, Inc.
General Hospital
101d
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
Dec 22, 2016
VPS Rhythm Device with TipTracker Technology
Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)
General Hospital
262d
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
Sep 06, 2016
CG+ Arrow JACC
Arrow International, Inc. (Subsidiary of Teleflex
General Hospital
71d
Cleared
Sep 01, 2016
Cathtong I PICC Catheter
L&Z Us, Inc.
General Hospital
275d
Cleared
Jun 14, 2016
PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
C.R. Bard, Inc.
General Hospital
333d
Cleared
Feb 05, 2016
Amecath Peripheral inserted Central Venous Catheter Sets
Ameco Medical Industries
General Hospital
130d
Cleared
Feb 04, 2016
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
General Hospital
62d
Cleared
Jan 28, 2016
CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
General Hospital
64d