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 C.R. Bard, Inc., Boston Scientific Corp and Bard Access Systems, Inc..

287
Total
287
Cleared
131d
Avg days
1983
Since
287 devices
25–48 of 287
Cleared Sep 25, 2002
BARDPORT X-PORT ISP PORT
K022983
C.R. Bard, Inc.
General Hospital · 16d
Cleared Oct 20, 1998
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888
Boston Scientific Corp
General Hospital · 64d
Cleared Mar 10, 1997
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
K964538
Boston Scientific Corp
General Hospital · 118d
Cleared Mar 06, 1997
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
K964066
C.R. Bard, Inc.
General Hospital · 147d
Cleared Mar 21, 1996
VASCULAR ACCESS PORT KIT
K955587
Boston Scientific Corp
General Hospital · 105d
Cleared Aug 10, 1995
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
K952748
United States Surgical, A Division of Tyco Healthc
General Hospital · 55d
Cleared Nov 03, 1987
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735
Medtronic Vascular
General Hospital · 49d
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 Apr 15, 1987
HICKMAN TITANIUM SUBCUTANEOUS PORT
K870260
C.R. Bard, Inc.
General Hospital · 82d
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 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 Nov 06, 1985
MEDTRONIC ACCESS PORT MODEL 8500
K853322
Medtronic Vascular
General Hospital · 90d