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
169–192 of 302
Cleared Sep 25, 2000
PERIPHERALLY INSERTED CENTRAL CATHETER
K001874
Utah Medical Products, Inc.
General Hospital · 97d
Cleared Sep 19, 2000
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
K001901
C.R. Bard, Inc.
General Hospital · 89d
Cleared Aug 03, 2000
VYGON 2 FR EPICUTANEO PUR-CATHETER
K993052
Vygon Corp.
General Hospital · 325d
Cleared Aug 03, 2000
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)
K993442
Vygon Corp.
General Hospital · 296d
Cleared Jan 18, 2000
FAS ENDOLUMINAL BRUSH
K993614
Fas Medical , Ltd.
General Hospital · 85d
Cleared Jan 13, 1999
VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)
K983544
Vygon Corp.
General Hospital · 96d
Cleared Dec 10, 1998
MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T
K983412
Medical Components, Inc.
General Hospital · 73d
Cleared Mar 24, 1998
ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
K980090
Luther Medical Products, Inc.
General Hospital · 74d
Cleared Dec 22, 1997
CATHETER TUNNELER
K972555
Gerard Medical, Inc.
General Hospital · 168d
Cleared Nov 24, 1997
PERIPHERALLY INSERTED CENTRAL
K971999
B.Braun Medical, Inc.
General Hospital · 178d
Cleared Nov 12, 1997
1.4 FR MAPCATH SENSOR STYLET
K973057
Navion Biomedical Corp.
General Hospital · 89d
Cleared Aug 01, 1997
DOUBLE LUMEN PICC
K970926
B.Braun Medical, Inc.
General Hospital · 141d
Cleared Jun 26, 1997
CLINICATH IR PERIPHERALLY INSERTED CATHETER
K970269
Sims Deltec, Inc.
General Hospital · 154d
Cleared Jun 02, 1997
PERIPHERALLY INSERTED CENTRAL CATHETER
K964929
B.Braun Medical, Inc.
General Hospital · 175d
Cleared Jun 02, 1997
SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER
K971085
B.Braun Medical, Inc.
General Hospital · 69d
Cleared Apr 16, 1997
PICC CATHETER/MIDLINE CATHETER
K964447
Menlo Care, Inc.
General Hospital · 161d
Cleared Apr 16, 1997
HR POLYURETHANE PICC AND MIDLINE CATHETERS
K964556
Johnson & Johnson Medical, Inc.
General Hospital · 154d
Cleared Apr 01, 1997
NEO-PICC
K970434
Klein-Baker Medical, Inc.
General Hospital · 55d
Cleared Mar 04, 1997
PERIPHERALLY INSERTED MEDLINE CATHETER
K963257
Arrow Intl., Inc.
General Hospital · 197d
Cleared Dec 12, 1996
CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)
K963806
Bmw Medical, Inc.
General Hospital · 80d
Cleared Nov 14, 1996
CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)
K963215
Bmw Medical, Inc.
General Hospital · 90d
Cleared Oct 18, 1996
CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)
K963097
Bmw Medical, Inc.
General Hospital · 70d
Cleared Oct 07, 1996
CATHETER INSERTION TRAY
K962849
Medcare Medical Group, Inc.
General Hospital · 77d
Cleared Sep 30, 1996
MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932
K960055
Pudenz-Schulte Medical Research Corp.
General Hospital · 270d