LJS · Class II · 21 CFR 880.5970

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
25–48 of 302
Cleared Jun 18, 2018
Sherlock 3CG+ T ip Confirmation System
K180560
C.R. Bard, Inc.
General Hospital · 109d
Cleared May 21, 2018
Biowy PlCC Catheter
K173956
Biowy Corporation
General Hospital · 144d
Cleared Apr 26, 2018
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers
K180548
C.R. Bard, Inc (Bard Has Joined Bd)
General Hospital · 56d
Cleared Apr 20, 2018
Hickman TriFusion Catheter
K172511
C.R. Bard, Inc.
General Hospital · 242d
Cleared Apr 12, 2018
C3 Wave System
K180567
Medical Components, Inc. (dba MedComp)
General Hospital · 38d
Cleared Feb 26, 2018
Vygon PICCs
K172899
Vygon USA
General Hospital · 157d
Cleared Feb 22, 2018
Silicone Peripherally Inserted Central Venous Catheter Set/Tray
K171994
Cook Incorporated
General Hospital · 234d
Cleared Feb 20, 2018
HydroPICC
K172885
Access Vascular, Inc.
General Hospital · 152d
Cleared Sep 29, 2017
Sherlock 3CG Tip Positioning System Stylet
K172397
C.R. Bard, Inc.
General Hospital · 52d
Cleared Apr 24, 2017
PowerPICC Provena Catheters with SOLO Valve Technology
K162441
C.R. Bard, Inc.
General Hospital · 236d
Cleared Feb 03, 2017
PICC Maximal Barrier Nursing Kit
K163452
Navilyst Medical, Inc.
General Hospital · 56d
Cleared Oct 25, 2016
PowerPICC Provena Catheters
K162443
C.R. Bard, Inc.
General Hospital · 55d
Cleared Oct 07, 2016
Turbo-Flo PICC Sets
K161496
Cook Incorporated
General Hospital · 128d
Cleared Jun 14, 2016
PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
K151985
C.R. Bard, Inc.
General Hospital · 333d
Cleared Sep 24, 2015
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
K152409
Navilyst Medical, Inc.
General Hospital · 29d
Cleared Mar 31, 2015
Xcela Power Injectable PICC
K150527
Navilyst Medical, Inc.
General Hospital · 29d
Cleared Mar 19, 2015
NMI PICC III and NMI PICC IV
K150448
Navilyst Medical, Inc.
General Hospital · 27d
Cleared Jan 27, 2015
Celerity PICC Tip Confirmation System
K142889
AngioDynamics, Inc.
General Hospital · 116d
Cleared Oct 17, 2014
Sherlock 3CG Tip Positioning System Stylet
K142267
C.R. Bard, Inc.
General Hospital · 63d
Cleared Oct 14, 2014
PICC Maximal Barrier Nursing Kit
K142616
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Sep 29, 2014
PRO-PICC WITH VALVE TECHNOLOGY
K141633
Medical Components, Inc.
General Hospital · 103d
Cleared Mar 14, 2014
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K140345
C.R. Bard, Inc.
General Hospital · 31d
Cleared Mar 05, 2014
NMI PICC IV
K140266
Navilyst Medical, Inc.
General Hospital · 30d
Cleared Dec 23, 2013
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
K133634
Cook, Inc.
General Hospital · 27d