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
Growing category - 4 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 65d recently vs 132d historically

FDA 510(k) Cleared Port & Catheter, Implanted, Subcutaneous, Intravascular Devices (Product Code LJT)

288 devices
1–24 of 288
Cleared Sep 05, 2025
Vaccess™ CT Low-Profile Power-Injectable Implantable Port
K252478
Bard Access Systems, Inc.
General Hospital · 29d
Cleared Jun 18, 2025
PowerPort™ isp Implantable Port
K251253
Bard Access Systems, Inc.
General Hospital · 56d
Cleared Oct 31, 2024
PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports
K242328
Bard Access Systems, Inc.
General Hospital · 86d
Cleared Dec 08, 2023
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port
K232737
Bard Peripheral Vascular, Inc.
General Hospital · 92d
Cleared May 22, 2020
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
K190559
AngioDynamics, Inc.
General Hospital · 444d
Cleared Jul 08, 2019
Bard Power-Injectable Implantable Ports (PowerPorts®)
K181446
C.R. Bard, Inc.
General Hospital · 402d
Cleared Jun 06, 2016
NMI DUAL PORT II
K151239
Navilyst Medical, Inc.
General Hospital · 392d
Cleared May 20, 2016
BardPort®, SlimPort®, and X-Port® Implanted Ports
K153359
C.R. Bard, Inc.
General Hospital · 182d
Cleared Dec 04, 2015
NMI Port, NMI Port II
K153228
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Nov 20, 2015
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
K150514
C.R. Bard, Inc.
General Hospital · 266d
Cleared May 21, 2015
Vital-Port Vascular Access System Power Injectable Port
K150733
Cook Incorporated
General Hospital · 62d
Cleared May 21, 2014
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
K140169
Cook Incorporated
General Hospital · 118d
Cleared Feb 14, 2014
POWERPORT IMPLANTABLE PORT
K133335
C.R. Bard, Inc.
General Hospital · 108d
Cleared Aug 08, 2013
NMI PORT II CATHETER
K131694
Navilyst Medical, Inc.
General Hospital · 59d
Cleared Jul 31, 2013
5F DIGNITY CT TITANIUM PORT
K130923
Medical Components, Inc.
General Hospital · 119d
Cleared Apr 30, 2013
NMI PORT
K122767
Navilyst Medical, Inc.
General Hospital · 232d
Cleared Nov 15, 2012
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
K122899
C.R. Bard, Inc.
General Hospital · 55d
Cleared Sep 17, 2012
DIGNITY POWER INJECTABLE TITANIUM PORT
K120281
Medical Components, Inc.
General Hospital · 230d
Cleared Jun 17, 2010
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
K101017
AngioDynamics, Inc.
General Hospital · 66d
Cleared Mar 01, 2010
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
K093414
Smiths Medical Asd, Inc.
General Hospital · 119d
Cleared Mar 27, 2009
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
K090512
C.R. Bard, Inc.
General Hospital · 29d
Cleared Sep 23, 2008
SMARTPORT CT VORTEX
K081472
AngioDynamics, Inc.
General Hospital · 119d
Cleared Jun 04, 2008
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
K081311
C.R. Bard, Inc.
General Hospital · 26d
Cleared Dec 19, 2007
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
K073423
C.R. Bard, Inc.
General Hospital · 14d

About Product Code LJT - Regulatory Context

510(k) Submission Activity

288 total 510(k) submissions under product code LJT since 1983, with 288 receiving FDA clearance (average review time: 131 days).

Submission volume has increased in recent years - 4 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 65 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 →