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., Therex Corp. and C.R. Bard, Inc..
288
Total
288
Cleared
131d
Avg days
1983
Since
288 devices
Cleared
Oct 01, 1996
PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER
Sims Deltec, Inc.
General Hospital
82d
Cleared
Sep 30, 1996
IDEAS' DUAL PORT
Ideas For Medicine, Inc.
General Hospital
77d
Cleared
Sep 20, 1996
PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS
Sims Deltec, Inc.
General Hospital
149d
Cleared
Jul 19, 1996
LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037
Arrow Intl., Inc.
General Hospital
84d
Cleared
Jul 19, 1996
LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
Arrow Intl., Inc.
General Hospital
80d
Cleared
Jul 18, 1996
A PORT DETACHED CATHETER SYSTEM CATALOG #1002
Arrow Intl., Inc.
General Hospital
85d
Cleared
May 24, 1996
TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)
Gerard Medical Enterprises, Inc.
General Hospital
262d
Cleared
Apr 26, 1996
THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER
Arrow Intl., Inc.
General Hospital
79d
Cleared
Apr 17, 1996
CELSITE PEDIATRIC VENOUS SYSTEM
B.Braun Medical, Inc.
General Hospital
329d
Cleared
Apr 15, 1996
THERAPORT VASCULAR ACCESS SYSTEM
Biocontrol Technology, Inc.
General Hospital
81d
Cleared
Mar 21, 1996
VASCULAR ACCESS PORT KIT
Boston Scientific Corp
General Hospital
105d
Cleared
Mar 21, 1996
A2 DETACHED DUAL PORT SYSTEM
Arrow Intl., Inc.
General Hospital
86d
Cleared
Feb 12, 1996
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
Sims Deltec, Inc.
General Hospital
77d
Cleared
Jan 26, 1996
STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
Strato/Infusaid, Inc.
General Hospital
183d
Cleared
Dec 01, 1995
CELSITE VENOUS ACCESS SYSTEM OTW
B.Braun Medical, Inc.
General Hospital
78d
Cleared
Nov 15, 1995
SIMS SILO NEEDLE DE-ACCESS ENCLOSURE
Sims Deltec, Inc.
General Hospital
713d
Cleared
Nov 15, 1995
VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM
Gish Biomedical, Inc.
General Hospital
51d
Cleared
Oct 02, 1995
VASPORT VASCULAR ACCESS PORT
Gish Biomedical, Inc.
General Hospital
63d
Cleared
Sep 19, 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
Arrow Intl., Inc.
General Hospital
81d
Cleared
Sep 13, 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
Therex Corp.
General Hospital
72d
Cleared
Sep 08, 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
Therex Corp.
General Hospital
71d
Cleared
Aug 29, 1995
TRIUMPH-1 PORT
Horizon Medical Products, Inc.
General Hospital
133d
Cleared
Aug 10, 1995
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
United States Surgical, A Division of Tyco Healthc
General Hospital
55d
Cleared
Jul 31, 1995
VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM
Med Institute, Inc.
General Hospital
144d