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
73–96 of 288
Cleared Jan 27, 2000
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
K994216
Sims Deltec, Inc.
General Hospital · 43d
Cleared Jan 03, 2000
CELSITE, MODELS ST401L, ST405L
K994111
B. Braun/Mcgaw
General Hospital · 28d
Cleared Dec 03, 1999
CATHETER INNOVATIONS IMPLANTABLE PORT
K993860
Catheter Innovations, Inc.
General Hospital · 18d
Cleared Nov 18, 1999
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
K992697
Sims Deltec, Inc.
General Hospital · 99d
Cleared Oct 21, 1999
CATHETER INNOVATIONS IMPLANTABLE PORT
K991897
Catheter Innovations, Inc.
General Hospital · 139d
Cleared Oct 19, 1999
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
K992880
Sims Deltec, Inc.
General Hospital · 53d
Cleared Nov 23, 1998
BPOS-IVAD STABILIZER
K983480
Bpos, Inc.
General Hospital · 52d
Cleared Oct 20, 1998
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888
Boston Scientific Corp
General Hospital · 64d
Cleared Sep 16, 1998
MINI POLYURETHANE CATHETER
K982507
Med Institute, Inc.
General Hospital · 58d
Cleared May 07, 1998
TRIMPORT
K974533
Gerard Medical, Inc.
General Hospital · 156d
Cleared Mar 02, 1998
THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012
K974475
Biocontrol Technology, Inc.
General Hospital · 96d
Cleared Feb 12, 1998
NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
K974829
Kawasumi Laboratories Co., Ltd.
General Hospital · 50d
Cleared Jan 22, 1998
PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A
K974471
Sims Deltec, Inc.
General Hospital · 57d
Cleared Jan 13, 1998
HUBERLOC
K973497
Medcare Medical Group, Inc.
General Hospital · 120d
Cleared Dec 29, 1997
PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS
K973862
Sims Deltec, Inc.
General Hospital · 81d
Cleared Dec 22, 1997
NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET
K971582
Nipro Medical Corp.
General Hospital · 236d
Cleared Nov 17, 1997
VITAL-PORT INFUSION PAL
K971140
Med Institute, Inc.
General Hospital · 234d
Cleared Apr 30, 1997
TARGET VITAL-PORT VASCULAR ACCESS SYSTEM
K970442
Med Institute, Inc.
General Hospital · 84d
Cleared Mar 14, 1997
NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
K964117
Kawasumi Laboratories Co., Ltd.
General Hospital · 150d
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 Jan 03, 1997
PORTSMART NEEDLE DE-ACCESS ENCLOSURE
K964559
Jireh, Inc.
General Hospital · 51d
Cleared Dec 16, 1996
CELSITE PORT WITH PRECONNECTED CATHETER
K962230
B.Braun Medical, Inc.
General Hospital · 189d
Cleared Oct 24, 1996
A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
K963684
Arrow Intl., Inc.
General Hospital · 73d