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 C.R. Bard, Inc., Boston Scientific Corp and Bard Access Systems, Inc..
287
Total
287
Cleared
131d
Avg days
1983
Since
287 devices
Cleared
Sep 25, 2002
BARDPORT X-PORT ISP PORT
C.R. Bard, Inc.
General Hospital
16d
Cleared
Oct 20, 1998
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
Boston Scientific Corp
General Hospital
64d
Cleared
Mar 10, 1997
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
Boston Scientific Corp
General Hospital
118d
Cleared
Mar 06, 1997
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
C.R. Bard, Inc.
General Hospital
147d
Cleared
Mar 21, 1996
VASCULAR ACCESS PORT KIT
Boston Scientific Corp
General Hospital
105d
Cleared
Aug 10, 1995
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
United States Surgical, A Division of Tyco Healthc
General Hospital
55d
Cleared
Nov 03, 1987
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
Medtronic Vascular
General Hospital
49d
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
Apr 15, 1987
HICKMAN TITANIUM SUBCUTANEOUS PORT
C.R. Bard, Inc.
General Hospital
82d
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
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
Nov 06, 1985
MEDTRONIC ACCESS PORT MODEL 8500
Medtronic Vascular
General Hospital
90d