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
25–48 of 288
Cleared Sep 17, 2012
DIGNITY POWER INJECTABLE TITANIUM PORT
K120281
Medical Components, Inc.
General Hospital · 230d
Cleared Nov 30, 2011
DIGNITY MINI PORT- ATTACHABLE
K110424
Medcomp ( Medical Components)
General Hospital · 289d
Cleared Oct 27, 2011
NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
K112713
Norfolk Medical Products, Inc.
General Hospital · 38d
Cleared Oct 13, 2011
INVISIPORT
K110407
Stealth Therapeutics, Incorporated
General Hospital · 241d
Cleared Aug 25, 2011
NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
K111101
Norfolk Medical
General Hospital · 127d
Cleared Jan 14, 2011
NORFOLK MEDICAL NORPORT FAMILY OF PORTS
K102385
Norfolk Medical Products, Inc.
General Hospital · 144d
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 Mar 07, 2008
JET PORT PLUS HP CATHETER SYSTEM
K072481
Pfm Medical, Inc.
General Hospital · 185d
Cleared Dec 19, 2007
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
K073423
C.R. Bard, Inc.
General Hospital · 14d
Cleared Dec 14, 2007
POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS
K072657
Smiths Medical MD, Inc.
General Hospital · 85d
Cleared Dec 12, 2007
MODIFICATION TO: T-PORT HP INFUSION PORT
K073210
Pfm Medical, Inc.
General Hospital · 28d
Cleared Nov 14, 2007
TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
K072549
C.R. Bard, Inc.
General Hospital · 65d
Cleared Nov 01, 2007
TITANIUM POWERPORT ISP IMPLANTED PORT
K072215
C.R. Bard, Inc.
General Hospital · 84d
Cleared Oct 17, 2007
T-PORT HP INFUSION PORT
K071993
Pfm Medical, Inc.
General Hospital · 89d
Cleared May 23, 2007
POWER PORT-A-CATH AND POWER PORT-A-CATH II
K070116
Smiths Medical MD, Inc.
General Hospital · 131d
Cleared May 15, 2007
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
K070003
Medcomp
General Hospital · 132d
Cleared Jan 25, 2007
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
K063377
C.R. Bard, Inc.
General Hospital · 78d
Cleared Jul 31, 2006
CELSITE/ CELSITE CONCEPT, ACCESS PORTS
K061424
Aesculap, Inc.
General Hospital · 69d
Cleared Jul 14, 2006
POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE
K060812
C.R. Bard, Inc.
General Hospital · 112d
Cleared May 17, 2006
PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER
K060036
Smiths Medical MD, Inc.
General Hospital · 132d