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., C.R. Bard, Inc. and Arrow Intl., Inc..

288
Total
288
Cleared
131d
Avg days
1983
Since
288 devices
97–120 of 288
Cleared Oct 27, 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213
C.R. Bard, Inc.
General Hospital · 74d
Cleared Jul 30, 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817
C.R. Bard, Inc.
General Hospital · 149d
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 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 10, 1986
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
K863305
C.R. Bard, Inc.
General Hospital · 46d
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 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