FDA Product Code LJT: Port & Catheter, Implanted, Subcutaneous, Intravascular
Implanted venous access ports provide long-term reliable vascular access. FDA product code LJT covers subcutaneously implanted intravascular port and catheter systems.
These totally implanted systems consist of a subcutaneous reservoir with a silicone septum connected to a central venous catheter, providing repeated vascular access for chemotherapy, blood sampling, and parenteral nutrition without repeated venipuncture.
LJT devices are Class II medical devices, regulated under 21 CFR 880.5965 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Strato Medical Corp., C.R. Bard, Inc. and Arrow Intl., Inc..
288
Total
288
Cleared
131d
Avg days
1983
Since
288 devices
Cleared
Apr 19, 1991
STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED
Strato Medical Corp.
Gastroenterology & Urology
113d
Cleared
Apr 19, 1991
STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED
Strato Medical Corp.
General Hospital
113d
Cleared
Apr 19, 1991
STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED
Strato Medical Corp.
General Hospital
113d
Cleared
Apr 19, 1991
STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED
Strato Medical Corp.
General Hospital
113d
Cleared
Apr 19, 1991
STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIED
Strato Medical Corp.
General Hospital
113d
Cleared
Apr 19, 1991
STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF
Strato Medical Corp.
General Hospital
113d
Cleared
Apr 19, 1991
STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED
Strato Medical Corp.
General Hospital
113d
Cleared
Apr 19, 1991
STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF
Strato Medical Corp.
General Hospital
113d
Cleared
Apr 19, 1991
STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED
Strato Medical Corp.
General Hospital
113d
Cleared
Apr 19, 1991
STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED
Strato Medical Corp.
General Hospital
113d
Cleared
Apr 15, 1991
LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015
Strato Medical Corp.
General Hospital
53d
Cleared
Apr 08, 1991
STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION
Strato Medical Corp.
General Hospital
102d
Cleared
Apr 08, 1991
LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI
Strato Medical Corp.
General Hospital
102d
Cleared
Apr 05, 1991
STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION
Strato Medical Corp.
General Hospital
99d
Cleared
Apr 05, 1991
STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED
Strato Medical Corp.
General Hospital
99d
Cleared
Apr 03, 1991
STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED
Strato Medical Corp.
General Hospital
97d
Cleared
Oct 10, 1990
PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
Pharmacia Deltec, Inc.
General Hospital
79d
Cleared
Mar 12, 1990
Q-PORT SYSTEM KIT
Quinton, Inc.
General Hospital
231d
Cleared
Dec 27, 1989
LIFEPORT VASCULAR ACCESS PORT
Strato Medical Corp.
General Hospital
96d
Cleared
Nov 17, 1989
LIFEPORT POLYURETHANE CATHETER
Strato Medical Corp.
General Hospital
44d
Cleared
Jun 03, 1988
LIFEPORT II, MODEL LPS-1100
Strato Medical Corp.
General Hospital
81d
Cleared
Apr 26, 1988
LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.
Strato Medical Corp.
General Hospital
92d
Cleared
Apr 13, 1988
PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM
Pharmacia Deltec, Inc.
General Hospital
111d
Cleared
Nov 03, 1987
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
Medtronic Vascular
General Hospital
49d