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
97–120 of 302
Cleared Jun 14, 2011
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K111244
Cook, Inc.
General Hospital · 42d
Cleared Dec 21, 2010
2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC
K102966
Medcomp
General Hospital · 77d
Cleared Nov 17, 2010
POWERPICC SV CATHETERS
K102159
C.R. Bard, Inc.
General Hospital · 107d
Cleared Sep 02, 2010
NMI IC
K101326
Navilyst Medical, Inc.
General Hospital · 114d
Cleared Aug 27, 2010
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
K100635
Arrow Intl., Inc.
General Hospital · 175d
Cleared Mar 25, 2010
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
K093406
AngioDynamics, Inc.
General Hospital · 143d
Cleared Feb 04, 2010
6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER
K093927
C.R. Bard, Inc.
General Hospital · 44d
Cleared Nov 24, 2009
NMI PICC II
K093366
Navilyst Medical, Inc.
General Hospital · 26d
Cleared Sep 16, 2009
PRO-PICC
K091953
Medcomp
General Hospital · 77d
Cleared Sep 16, 2009
PRO-PICC CT
K092347
Medcomp
General Hospital · 43d
Cleared Aug 07, 2009
SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET
K091324
C.R. Bard, Inc.
General Hospital · 94d
Cleared Jul 23, 2009
VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN
K091586
Medcomp
General Hospital · 51d
Cleared Jul 01, 2009
BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER
K091670
Becton, Dickinson & CO
General Hospital · 22d
Cleared Jun 17, 2009
1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
K091466
Medcomp
General Hospital · 30d
Cleared May 12, 2009
NMI PICC
K091261
Navilyst Medical, Inc.
General Hospital · 13d
Cleared Mar 19, 2009
PICC (CT RATED AND NON-RATED)
K083873
Pfm Medical, Inc.
General Hospital · 80d
Cleared Sep 23, 2008
PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)
K081904
Medcomp
General Hospital · 82d
Cleared Jun 27, 2008
PRESSURE INJFECTABLE PICC
K080604
Arrow International, Inc.
General Hospital · 115d
Cleared Jan 15, 2008
PRESSURE INJECTABLE PICC
K073451
Arrow International, Inc.
General Hospital · 36d
Cleared Dec 13, 2007
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K072625
Cook, Inc.
General Hospital · 87d
Cleared Nov 26, 2007
PRO-PICC, BASIC TRAY
K072509
Medcomp
General Hospital · 81d
Cleared Nov 19, 2007
PFM PICC
K072391
Pfm Medical, Inc.
General Hospital · 87d
Cleared Nov 05, 2007
V-CATH POLY PICC
K071875
Hdc Corp.
General Hospital · 122d
Cleared Oct 05, 2007
POWERPICC SOLO
K072230
C.R. Bard, Inc.
General Hospital · 56d