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
145–168 of 302
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 Dec 10, 2004
KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304
K042461
Kendall
General Hospital · 91d
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 Jul 02, 2003
LIFEVALVE CENTRAL VENOUS CATHTER
K031718
Horizon Medical Products, Inc.
General Hospital · 29d
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
Cleared Sep 10, 2001
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902
C.R. Bard, Inc.
General Hospital · 12d
Cleared Aug 01, 2001
CENTRAL VENOUS CATHETER
K003839
Boston Scientific Corp
General Hospital · 232d
Cleared Jan 26, 2001
MEDCOMP Z-CATH
K003682
Medical Components, Inc.
General Hospital · 57d
Cleared Dec 29, 2000
SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20
K992424
Plastimed Laboratoire Pharmaceutique
General Hospital · 527d
Cleared Dec 01, 2000
MEDCOMP BIO-CATH CATHETER LINE
K003110
Medcomp
General Hospital · 58d