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
217–240 of 288
Cleared May 06, 1987
LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER
K870886
Strato Medical Corp.
General Hospital · 62d
Cleared Apr 15, 1987
HICKMAN TITANIUM SUBCUTANEOUS PORT
K870260
C.R. Bard, Inc.
General Hospital · 82d
Cleared Apr 15, 1987
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
K870519
Norfolk Medical Products, Inc.
General Hospital · 68d
Cleared Mar 31, 1987
PORT-A-CATH VASCULAR ACCESS SYSTEMS
K864446
Pharmacia, Inc.
General Hospital · 139d
Cleared Feb 10, 1987
MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT
K864349
C.R. Bard, Inc.
General Hospital · 98d
Cleared Dec 01, 1986
HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER
K863750
C.R. Bard, Inc.
General Hospital · 67d
Cleared Nov 13, 1986
LIFE-PORT IMPLANTABLE VASCULAR ACCESS
K853827
Strato Medical Corp.
General Hospital · 426d
Cleared Oct 29, 1986
NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT
K863723
Norfolk Medical Products, Inc.
General Hospital · 36d
Cleared Oct 10, 1986
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
K863305
C.R. Bard, Inc.
General Hospital · 46d
Cleared Jul 17, 1986
HDC CHEMO-PORT (VASCULAR)
K853332
Hdc Corp.
General Hospital · 343d
Cleared Jun 12, 1986
MEDTRONIC MODEL 8501 ACCESS PORT
K861498
Medtronic Vascular
General Hospital · 50d
Cleared Jan 09, 1986
IMPLANTOFIX
K851293
Burron Medical Products, Inc.
General Hospital · 283d
Cleared Nov 06, 1985
MEDTRONIC ACCESS PORT MODEL 8500
K853322
Medtronic Vascular
General Hospital · 90d
Cleared Jun 28, 1984
VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD
K841679
Norfolk Medical Products, Inc.
General Hospital · 66d
Cleared Apr 24, 1984
VASCULAR ACCESS PORT CHANGES IN MATER
K840788
Norfolk Medical Products, Inc.
General Hospital · 109d
Cleared Apr 24, 1984
VASCULAR-ACCESS PORT - ENLARGEMENT
K841149
Norfolk Medical Products, Inc.
General Hospital · 109d
Cleared Apr 24, 1984
VASCULAR-ACCESS PORT CHANGE CATHETER
K841150
Norfolk Medical Products, Inc.
General Hospital · 47d
Cleared Dec 28, 1983
PORT-A-CATH
K832917
Pharmacia, Inc.
General Hospital · 121d
Cleared Jun 30, 1983
PORT-A-CATH IMPLANTABLE CATH. SYS
K830730
Pharmacia, Inc.
General Hospital · 114d
Cleared Mar 01, 1983
VASCULAR-ACCESS-PORT
K830000
Norfolk Medical Products, Inc.
General Hospital · 57d