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
Growing category -
3 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
57d
recently vs 132d historically
FDA 510(k) Cleared Port & Catheter, Implanted, Subcutaneous, Intravascular Devices (Product Code LJT)
287 devices
Cleared
Sep 05, 2025
Vaccess™ CT Low-Profile Power-Injectable Implantable Port
Bard Access Systems, Inc.
General Hospital
29d
Cleared
Jun 18, 2025
PowerPort™ isp Implantable Port
Bard Access Systems, Inc.
General Hospital
56d
Cleared
Oct 31, 2024
PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports
Bard Access Systems, Inc.
General Hospital
86d
Cleared
Dec 08, 2023
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port
Bard Peripheral Vascular, Inc.
General Hospital
92d
Cleared
May 22, 2020
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
AngioDynamics, Inc.
General Hospital
444d
Cleared
Jul 08, 2019
Bard Power-Injectable Implantable Ports (PowerPorts®)
C.R. Bard, Inc.
General Hospital
402d
Cleared
May 20, 2016
BardPort®, SlimPort®, and X-Port® Implanted Ports
C.R. Bard, Inc.
General Hospital
182d
Cleared
Nov 20, 2015
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
C.R. Bard, Inc.
General Hospital
266d
Cleared
Feb 14, 2014
POWERPORT IMPLANTABLE PORT
C.R. Bard, Inc.
General Hospital
108d
Cleared
Nov 15, 2012
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
C.R. Bard, Inc.
General Hospital
55d
Cleared
Mar 27, 2009
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
C.R. Bard, Inc.
General Hospital
29d
Cleared
Jun 04, 2008
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
C.R. Bard, Inc.
General Hospital
26d
Cleared
Dec 19, 2007
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
C.R. Bard, Inc.
General Hospital
14d
Cleared
Nov 14, 2007
TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
C.R. Bard, Inc.
General Hospital
65d
Cleared
Nov 01, 2007
TITANIUM POWERPORT ISP IMPLANTED PORT
C.R. Bard, Inc.
General Hospital
84d
Cleared
Jan 25, 2007
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
C.R. Bard, Inc.
General Hospital
78d
Cleared
Jul 14, 2006
POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE
C.R. Bard, Inc.
General Hospital
112d
Cleared
Jan 15, 2004
MODIFICATION TO X-PORT DUO PORT
C.R. Bard, Inc.
General Hospital
17d
Cleared
Sep 09, 2003
VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233
Boston Scientific Corp
General Hospital
15d
Cleared
Aug 19, 2003
VAXCEL PORT, MODELS 45-336 AND 45-338
Boston Scientific Corp
General Hospital
18d
Cleared
Jul 15, 2003
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
Boston Scientific Corp
General Hospital
29d
Cleared
Jul 14, 2003
VAXCEL WITH PASV PORT, MODEL 45-213
Boston Scientific Corp
General Hospital
14d
Cleared
Jul 10, 2003
X-PROT DUO PORT
C.R. Bard, Inc.
General Hospital
8d
Cleared
Jan 28, 2003
VAXCEL WITH PASV PORT
Boston Scientific Corp
General Hospital
19d
About Product Code LJT - Regulatory Context
510(k) Submission Activity
287 total 510(k) submissions under product code LJT since 1983, with 287 receiving FDA clearance (average review time: 131 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - LJT Product Code
Recent submissions under LJT have taken an average of 57 days to reach a decision - down from 132 days historically, suggesting improved FDA processing for this classification.
LJT devices are reviewed by the General Hospital panel. Browse all General Hospital devices →