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
217–240 of 302
Cleared Mar 07, 1994
3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH
K926331
Bard Access Systems, Inc.
General Hospital · 446d
Cleared Feb 07, 1994
RIGHT ATRIAL CATHETER
K930630
Akcess Medical Products, Inc.
General Hospital · 364d
Cleared Dec 30, 1993
STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM
K933884
Strato Medical Corp.
General Hospital · 142d
Cleared Dec 13, 1993
STRATO MEDICAL SINGLE LUMEN VALVED CATHETER
K924851
Strato Medical Corp.
General Hospital · 441d
Cleared Jul 30, 1993
STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH
K924677
Strato Medical Corp.
General Hospital · 317d
Cleared Jul 07, 1993
INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER
K921751
Strato Medical Corp.
General Hospital · 450d
Cleared Jun 07, 1993
L-CATH PEEL AWAY SYSTEM CATHETER
K920755
Luther Medical Products, Inc.
General Hospital · 474d
Cleared May 13, 1993
NEEDLELESS INJECTION CANNULA
K923653
Arrow Intl., Inc.
General Hospital · 296d
Cleared Oct 23, 1992
8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS
K921755
Davol, Inc.
General Hospital · 193d
Cleared Apr 19, 1991
8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER
K910486
Davol, Inc.
General Hospital · 72d
Cleared Mar 29, 1991
GESCO PER-Q-CATH REPAIR KIT
K910622
Gesco Intl., Inc.
General Hospital · 45d
Cleared Mar 07, 1991
VYGON LIFEVAC PICC
K903648
Vygon Corp.
General Hospital · 206d
Cleared Nov 05, 1990
PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT
K904334
Pharmacia Deltec, Inc.
General Hospital · 45d
Cleared Sep 21, 1990
WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER
K895543
Strato Medical Corp.
General Hospital · 373d
Cleared Apr 25, 1990
STRATO INDWELLING CATHETER
K896598
Strato Medical Corp.
General Hospital · 155d
Cleared Apr 23, 1990
EPICUTANEO-CAVA CATHETER CODE 2184
K897168
Vygon Corp.
General Hospital · 117d
Cleared Dec 15, 1989
PERCUTANEOUS INTRAVENOUS CATHETERS
K895712
Pharmacia Deltec, Inc.
General Hospital · 81d
Cleared Dec 05, 1989
DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS
K892926
Vas-Cath, Inc.
General Hospital · 228d
Cleared Aug 10, 1989
DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE
K893126
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 107d
Cleared Oct 04, 1988
PMT VASCULAR CATHETER MODEL NUMBER 3621-1
K883313
Pmt Corp.
General Hospital · 60d
Cleared Aug 09, 1988
MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE
K882448
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 56d
Cleared Apr 03, 1987
VAPOR-SEAL(TM) PERCUTANEOUS CATHETERS
K864086
Pharmacia, Inc.
General Hospital · 165d
Cleared Mar 14, 1986
GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
K851243
Cook, Inc.
General Hospital · 381d
Cleared Jun 07, 1985
VASCULAR ACCESS CATHETER
K851195
Sil-Med Corp.
General Hospital · 73d