LJT · Class II · 21 CFR 880.5965

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
97–120 of 288
Cleared Oct 01, 1996
PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER
K962695
Sims Deltec, Inc.
General Hospital · 82d
Cleared Sep 30, 1996
IDEAS' DUAL PORT
K962751
Ideas For Medicine, Inc.
General Hospital · 77d
Cleared Sep 20, 1996
PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS
K961580
Sims Deltec, Inc.
General Hospital · 149d
Cleared Jul 19, 1996
LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037
K961615
Arrow Intl., Inc.
General Hospital · 84d
Cleared Jul 19, 1996
LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
K961652
Arrow Intl., Inc.
General Hospital · 80d
Cleared Jul 18, 1996
A PORT DETACHED CATHETER SYSTEM CATALOG #1002
K961583
Arrow Intl., Inc.
General Hospital · 85d
Cleared May 24, 1996
TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)
K954258
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
K960572
Arrow Intl., Inc.
General Hospital · 79d
Cleared Apr 17, 1996
CELSITE PEDIATRIC VENOUS SYSTEM
K952435
B.Braun Medical, Inc.
General Hospital · 329d
Cleared Apr 15, 1996
THERAPORT VASCULAR ACCESS SYSTEM
K960350
Biocontrol Technology, Inc.
General Hospital · 81d
Cleared Mar 21, 1996
VASCULAR ACCESS PORT KIT
K955587
Boston Scientific Corp
General Hospital · 105d
Cleared Mar 21, 1996
A2 DETACHED DUAL PORT SYSTEM
K955819
Arrow Intl., Inc.
General Hospital · 86d
Cleared Feb 12, 1996
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
K955407
Sims Deltec, Inc.
General Hospital · 77d
Cleared Jan 26, 1996
STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
K953529
Strato/Infusaid, Inc.
General Hospital · 183d
Cleared Dec 01, 1995
CELSITE VENOUS ACCESS SYSTEM OTW
K954297
B.Braun Medical, Inc.
General Hospital · 78d
Cleared Nov 15, 1995
SIMS SILO NEEDLE DE-ACCESS ENCLOSURE
K935767
Sims Deltec, Inc.
General Hospital · 713d
Cleared Nov 15, 1995
VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K954433
Gish Biomedical, Inc.
General Hospital · 51d
Cleared Oct 02, 1995
VASPORT VASCULAR ACCESS PORT
K953571
Gish Biomedical, Inc.
General Hospital · 63d
Cleared Sep 19, 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
K953073
Arrow Intl., Inc.
General Hospital · 81d
Cleared Sep 13, 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
K953110
Therex Corp.
General Hospital · 72d
Cleared Sep 08, 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
K953017
Therex Corp.
General Hospital · 71d
Cleared Aug 29, 1995
TRIUMPH-1 PORT
K951814
Horizon Medical Products, Inc.
General Hospital · 133d
Cleared Aug 10, 1995
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
K952748
United States Surgical, A Division of Tyco Healthc
General Hospital · 55d
Cleared Jul 31, 1995
VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM
K951077
Med Institute, Inc.
General Hospital · 144d