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
145–168 of 288
Cleared Feb 25, 1994
HMP TITANIUM PORT
K933990
Horizon Medical Products, Inc.
General Hospital · 192d
Cleared Feb 25, 1994
HMP DUAL TITANIUM PORT
K934504
Horizon Medical Products, Inc.
General Hospital · 163d
Cleared Feb 25, 1994
HMP TITANIUM LOW PROFILE PORT
K934573
Horizon Medical Products, Inc.
General Hospital · 157d
Cleared Feb 25, 1994
HMP DUAL POLYSULFONE PORT
K934640
Horizon Medical Products, Inc.
General Hospital · 150d
Cleared Feb 23, 1994
THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM
K933316
Therex Corp.
General Hospital · 231d
Cleared Feb 23, 1994
THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM
K933350
Therex Corp.
General Hospital · 229d
Cleared Feb 09, 1994
THEREX LOW-PROFILE PORT .6MM I.D 2.3MM O.D.
K932447
Therex Corp.
General Hospital · 265d
Cleared Feb 07, 1994
THEREX R-PORT
K932671
Therex Corp.
General Hospital · 250d
Cleared Feb 03, 1994
V.A.D. ACCESS KIT
K932010
Clinipad Corp.
General Hospital · 286d
Cleared Jan 07, 1994
STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT
K932509
Strato Medical Corp.
General Hospital · 227d
Cleared Jan 05, 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S
K932095
Pharmacia Deltec, Inc.
General Hospital · 250d
Cleared Jan 05, 1994
PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM
K932840
Pharmacia Deltec, Inc.
General Hospital · 208d
Cleared Jan 05, 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS
K932841
Pharmacia Deltec, Inc.
General Hospital · 208d
Cleared Oct 04, 1993
PLASTIC LOW PROFILE SUBCUTANEOUS PORT
K924250
Bard Access Systems, Inc.
General Hospital · 406d
Cleared Jul 28, 1993
PORT ACCESS NEEDLE
K921902
Kawasumi Laboratories Co., Ltd.
General Hospital · 462d
Cleared Jul 28, 1993
VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P
K924748
Med Institute, Inc.
General Hospital · 309d
Cleared Jul 07, 1993
LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555
K915273
Strato Medical Corp.
General Hospital · 590d
Cleared Jun 17, 1993
SNAP-LOCK MICROPORT - REVISED
K924505
Strato Medical Corp.
General Hospital · 286d
Cleared May 06, 1993
THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D
K925373
Therex Corp.
General Hospital · 195d
Cleared Apr 21, 1993
PHARMACIA DELTEC WINGED INFUSION SET
K923019
Pharmacia Deltec, Inc.
General Hospital · 302d
Cleared Mar 20, 1993
VITAL-PORT VASCULAR ACCESS SYSTEM W/ INJECTROL
K922896
Med Institute, Inc.
General Hospital · 277d
Cleared Mar 19, 1993
A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI
K926011
Therex Corp.
General Hospital · 123d
Cleared Nov 20, 1992
IPI IMPORT
K922419
Pudenz-Schulte Medical Research Corp.
General Hospital · 183d
Cleared Nov 06, 1992
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT
K921379
Therex Corp.
General Hospital · 228d