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
121–144 of 302
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 24, 2006
ARROW PRESSURE INJECTABLE PICC
K061289
Arrow International, Inc.
General Hospital · 107d
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
Cleared Mar 17, 2006
PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
K053345
Medcomp
General Hospital · 105d
Cleared Jan 13, 2006
POWERPICC
K053501
Bard Access Systems, Inc.
General Hospital · 28d
Cleared Nov 23, 2005
OMNIPICC PI
K051102
Rita Medical Systems, Inc.
General Hospital · 208d
Cleared Nov 23, 2005
POWERPICC
K051672
Bard Access Systems, Inc.
General Hospital · 153d
Cleared Oct 20, 2005
POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE
K051991
C.R. Bard, Inc.
General Hospital · 90d
Cleared Aug 26, 2005
FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH
K050889
Crs Medical Diagnostics, Inc.
General Hospital · 142d
Cleared Aug 19, 2005
VYGON NUTRILINE CATHETERS
K051690
Vygon Corp.
General Hospital · 57d
Cleared Jul 26, 2005
MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER
K050542
Marian Medical, Inc.
General Hospital · 146d
Cleared Jul 25, 2005
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669
K051194
Becton, Dickinson & CO
General Hospital · 76d
Cleared Jul 21, 2005
TURBO-FLO PICC
K041849
Cook, Inc.
General Hospital · 378d
Cleared Jun 30, 2005
6 FR FL POWERHOHN AND POWERLINE CATHETER
K051417
C.R. Bard, Inc.
General Hospital · 29d
Cleared Jun 15, 2005
6 FR DL POWERPICC CATHETER
K050931
C.R. Bard, Inc.
General Hospital · 62d