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 Dec 06, 2017
C3 Wave System
K170934
Medical Components, Inc. (dba MedComp)
General Hospital · 251d
Cleared Oct 26, 2017
Celerity ECG Cable Accessory Pack
K171931
Medcomp (Medical Components, Inc.)
General Hospital · 120d
Cleared Sep 29, 2017
Sherlock 3CG Tip Positioning System Stylet
K172397
C.R. Bard, Inc.
General Hospital · 52d
Cleared Aug 03, 2017
CATHTONG II PICC Catheter
K172039
L&Z Us, Inc.
General Hospital · 29d
Cleared May 25, 2017
CATHTONG II PICC Catheter
K170486
L&Z Us, Inc.
General Hospital · 101d
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 Dec 22, 2016
VPS Rhythm Device with TipTracker Technology
K160925
Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)
General Hospital · 262d
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 Sep 06, 2016
CG+ Arrow JACC
K161765
Arrow International, Inc. (Subsidiary of Teleflex
General Hospital · 71d
Cleared Sep 01, 2016
Cathtong I PICC Catheter
K153469
L&Z Us, Inc.
General Hospital · 275d
Cleared Jun 14, 2016
PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
K151985
C.R. Bard, Inc.
General Hospital · 333d
Cleared Feb 05, 2016
Amecath Peripheral inserted Central Venous Catheter Sets
K152819
Ameco Medical Industries
General Hospital · 130d
Cleared Feb 04, 2016
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
K153487
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
K153423
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
General Hospital · 64d