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 Mar 17, 2006
PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
K053345
Medcomp
General Hospital · 105d
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 19, 2005
VYGON NUTRILINE CATHETERS
K051690
Vygon Corp.
General Hospital · 57d
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
Cleared May 26, 2005
POWERHOHN AND POWERLINE CATHETERS
K050185
C.R. Bard, Inc.
General Hospital · 119d
Cleared Jan 14, 2005
6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
K043502
C.R. Bard, Inc.
General Hospital · 25d
Cleared Nov 22, 2004
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER
K042491
Becton, Dickinson & CO
General Hospital · 69d
Cleared Nov 01, 2004
TRIFUSION, MODEL 0609190/0659350
K041088
C.R. Bard, Inc.
General Hospital · 189d
Cleared Sep 09, 2004
PREMICATH, 1261.205
K041468
Vygon Corp.
General Hospital · 99d
Cleared Aug 27, 2004
PICC
K042126
Arrow Intl., Inc.
General Hospital · 21d
Cleared Jul 26, 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K041420
AngioDynamics, Inc.
General Hospital · 59d
Cleared Mar 19, 2004
POWERPICC CATHETERS, MODELS 3175155, 3175135
K033389
C.R. Bard, Inc.
General Hospital · 148d
Cleared Mar 05, 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K040446
AngioDynamics, Inc.
General Hospital · 14d
Cleared Jan 21, 2004
POLY PER-Q-CATH PICC CATHETERS
K034019
C.R. Bard, Inc.
General Hospital · 28d
Cleared Jan 21, 2004
GROSHONG NXT PICC CATHETERS
K034020
C.R. Bard, Inc.
General Hospital · 28d
Cleared Jun 19, 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K031626
AngioDynamics, Inc.
General Hospital · 23d
Cleared May 05, 2003
POLY PER-Q-CATH PICC CATHETERS
K031129
C.R. Bard, Inc.
General Hospital · 26d
Cleared Apr 30, 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K030415
AngioDynamics, Inc.
General Hospital · 82d
Cleared Apr 11, 2003
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON
K030270
Medcomp
General Hospital · 74d
Cleared Feb 07, 2003
SILICONE DUAL LUMEN RADPICC CATHETERS
K030255
C.R. Bard, Inc.
General Hospital · 14d
Cleared Dec 18, 2002
GROSHONG NXT DUAL LUMEN PICC CATHETERS
K023374
C.R. Bard, Inc.
General Hospital · 71d