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
193–216 of 302
Cleared Sep 05, 1996
CLAMPLESS VALVED CATHETER
K962300
Bmw Medical, Inc.
General Hospital · 84d
Cleared Jul 18, 1996
MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652
K961336
Medtronic PS Medical
General Hospital · 101d
Cleared Jul 18, 1996
AUTO SUTURE CHEMOSITE TUNNELER
K961856
United States Surgical, A Division of Tyco Healthc
General Hospital · 65d
Cleared Jun 18, 1996
SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908
K961155
Douglas Medical Products Corp.
General Hospital · 88d
Cleared Jun 17, 1996
VYGON PREMI-CATH - LONG TERM CATHETER
K954302
Vygon Corp.
General Hospital · 278d
Cleared Apr 30, 1996
V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER
K953300
Hdc Corp.
General Hospital · 291d
Cleared Apr 22, 1996
5 FR PICC-LINE CATHETER
K954638
Vygon Corp.
General Hospital · 199d
Cleared Jan 04, 1996
STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS
K954720
Strato/Infusaid, Inc.
General Hospital · 83d
Cleared Dec 18, 1995
PS MEDICAL IPI VASCULAR ACCESS CATHETER
K954409
Pudenz-Schulte Medical Research Corp.
General Hospital · 89d
Cleared Dec 15, 1995
PER-Q-CATH MID-LINE
K954422
Gesco Intl., Inc.
General Hospital · 85d
Cleared Nov 21, 1995
PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES
K954104
C.R. Bard, Inc.
General Hospital · 82d
Cleared Jul 31, 1995
CATHETER, INTRAVASCULAR OR PERCUTANEOUS
K951078
Sims Deltec, Inc.
General Hospital · 144d
Cleared Jun 06, 1995
STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
K945956
Strato Medical Corp.
General Hospital · 182d
Cleared Jun 02, 1995
HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER
K951098
Hdc Corp.
General Hospital · 85d
Cleared May 02, 1995
STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS
K946250
Strato Medical Corp.
General Hospital · 130d
Cleared Feb 17, 1995
VASCULAR ACCESS CATHETER ACCESSORIES
K935380
Bard Access Systems, Inc.
General Hospital · 466d
Cleared May 02, 1994
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K932198
Pharmacia Deltec, Inc.
General Hospital · 361d
Cleared May 02, 1994
PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS
K932211
Pharmacia Deltec, Inc.
General Hospital · 360d
Cleared May 02, 1994
DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER
K932430
Pharmacia Deltec, Inc.
General Hospital · 347d
Cleared May 02, 1994
PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE
K932433
Pharmacia Deltec, Inc.
General Hospital · 347d
Cleared May 02, 1994
PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH.
K932464
Pharmacia Deltec, Inc.
General Hospital · 346d
Cleared Apr 07, 1994
ONECATH L-CATH CATHETER SYSTEM
K930473
Luther Medical Products, Inc.
General Hospital · 434d
Cleared Mar 28, 1994
ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER
K930129
Arrow Intl., Inc.
General Hospital · 440d
Cleared Mar 22, 1994
L CATH(R) CATHETER SYSTEM
K925236
Luther Medical Products, Inc.
General Hospital · 522d