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
Oct 27, 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
C.R. Bard, Inc.
General Hospital
74d
Cleared
Jul 30, 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
C.R. Bard, Inc.
General Hospital
149d
Cleared
May 06, 1987
LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER
Strato Medical Corp.
General Hospital
62d
Cleared
Apr 15, 1987
HICKMAN TITANIUM SUBCUTANEOUS PORT
C.R. Bard, Inc.
General Hospital
82d
Cleared
Mar 31, 1987
PORT-A-CATH VASCULAR ACCESS SYSTEMS
Pharmacia, Inc.
General Hospital
139d
Cleared
Feb 10, 1987
MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT
C.R. Bard, Inc.
General Hospital
98d
Cleared
Dec 01, 1986
HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER
C.R. Bard, Inc.
General Hospital
67d
Cleared
Nov 13, 1986
LIFE-PORT IMPLANTABLE VASCULAR ACCESS
Strato Medical Corp.
General Hospital
426d
Cleared
Oct 10, 1986
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
C.R. Bard, Inc.
General Hospital
46d
Cleared
Jun 12, 1986
MEDTRONIC MODEL 8501 ACCESS PORT
Medtronic Vascular
General Hospital
50d
Cleared
Jan 09, 1986
IMPLANTOFIX
Burron Medical Products, Inc.
General Hospital
283d
Cleared
Nov 06, 1985
MEDTRONIC ACCESS PORT MODEL 8500
Medtronic Vascular
General Hospital
90d
Cleared
Dec 28, 1983
PORT-A-CATH
Pharmacia, Inc.
General Hospital
121d
Cleared
Jun 30, 1983
PORT-A-CATH IMPLANTABLE CATH. SYS
Pharmacia, Inc.
General Hospital
114d