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
49–72 of 302
Cleared Oct 21, 2015
PICC Tip Positioning Aid
K152261
Nostix, LLC
General Hospital · 71d
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 Apr 24, 2015
C3 Wave
K143238
Medcomp ( Medical Components)
General Hospital · 163d
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
NAUTILUS DELTA
K141634
Romedex International Srl
General Hospital · 223d
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 Aug 05, 2014
TURBO-JECT PICC SETS
K141818
Cook Corporated
General Hospital · 29d
Cleared Jul 08, 2014
CT MIDLINE
K141151
Medcomp (Medical Components, Inc.)
General Hospital · 64d
Cleared Jun 13, 2014
CELERITY SYSYEM
K140799
Medcomp (Medical Components, Inc.)
General Hospital · 74d
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
Cleared Nov 20, 2013
NMI PICC III
K133264
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Nov 05, 2013
ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN
K132567
Covidien
General Hospital · 82d
Cleared Oct 22, 2013
MEDCOMP VASCU-PICC WITH VALVE
K130897
Medcomp ( Medical Components)
General Hospital · 204d
Cleared Oct 11, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132885
Cook Incorporated
General Hospital · 25d
Cleared Aug 16, 2013
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
K131687
Medical Components, Inc.
General Hospital · 67d
Cleared Aug 16, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132334
Cook, Inc.
General Hospital · 21d
Cleared Jul 31, 2013
NMI PICC III CATHETER, NMI HPICC III CATHETER
K131942
Navilyst Medical, Inc.
General Hospital · 34d
Cleared Jun 03, 2013
FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
K130507
Footprint Medical, Inc.
General Hospital · 96d