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
73–96 of 302
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 Sep 23, 2008
PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)
K081904
Medcomp
General Hospital · 82d
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 Oct 05, 2007
POWERPICC SOLO
K072230
C.R. Bard, Inc.
General Hospital · 56d
Cleared Aug 27, 2007
ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT
K072196
AngioDynamics, Inc.
General Hospital · 20d
Cleared Aug 17, 2007
BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
K070002
Boston Scientific
General Hospital · 226d
Cleared Jun 29, 2007
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
K070613
AngioDynamics, Inc.
General Hospital · 116d
Cleared May 08, 2007
4 FR SINGLE LUMEN (SL) POWERPICC CATHETER
K070996
C.R. Bard, Inc.
General Hospital · 29d
Cleared May 04, 2007
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
K070615
AngioDynamics, Inc.
General Hospital · 60d
Cleared Apr 04, 2007
POWERGROSHONG PICC CATHETER
K063848
C.R. Bard, Inc.
General Hospital · 97d
Cleared Nov 21, 2006
SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR
K063240
C.R. Bard, Inc.
General Hospital · 26d
Cleared Sep 15, 2006
LIFECATH S PICC AND MIDLINE CATHETER
K062425
Vygon Corp.
General Hospital · 28d
Cleared Aug 09, 2006
POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER
K061179
C.R. Bard, Inc.
General Hospital · 104d
Cleared Aug 03, 2006
1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50
K061986
Medcomp
General Hospital · 21d
Cleared Apr 28, 2006
ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT
K060887
AngioDynamics, Inc.
General Hospital · 28d