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
121–144 of 288
Cleared Jul 21, 1995
CELSITE VENOUS SYSTEM
K952548
B.Braun Medical, Inc.
General Hospital · 49d
Cleared Jul 06, 1995
THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.
K952537
Therex Corp.
General Hospital · 36d
Cleared Jun 13, 1995
VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM
K951076
Med Institute, Inc.
General Hospital · 96d
Cleared May 31, 1995
CELSITE(TM) BRACHIAL VENOUS PORT
K945752
B. Braun of America, Inc.
General Hospital · 189d
Cleared May 02, 1995
NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED
K942784
Norfolk Medical Products, Inc.
General Hospital · 322d
Cleared Apr 21, 1995
CELSITE(TM) DUAL VENOUS SYSTEM
K945551
B. Braun of America, Inc.
General Hospital · 158d
Cleared Apr 13, 1995
A2 DETACHED DUAL PORT SYSTEM
K950212
Therex Corp.
General Hospital · 84d
Cleared Mar 23, 1995
1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL
K950131
Therex Corp.
General Hospital · 69d
Cleared Feb 01, 1995
STRATO MEDICAL LIFEPORT LPS 7515
K942848
Strato Medical Corp.
General Hospital · 230d
Cleared Jan 27, 1995
STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM
K934518
Strato Medical Corp.
General Hospital · 497d
Cleared Jan 03, 1995
CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH
K926139
Bard Access Systems, Inc.
General Hospital · 757d
Cleared Sep 19, 1994
VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA
K932411
Med Institute, Inc.
General Hospital · 489d
Cleared Sep 06, 1994
VITAL-PORT VASCULAR ACCESS SYSTEM
K934520
Med Institute, Inc.
General Hospital · 351d
Cleared Aug 19, 1994
THEREX LOW-PROFILE PORT - TITANIUM MODEL
K942412
Therex Corp.
General Hospital · 91d
Cleared Jul 26, 1994
PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM
K942024
Pharmacia Deltec, Inc.
General Hospital · 91d
Cleared Jul 26, 1994
L-CATH CATHETER SYSTEM - PORT L-CATH
K942103
Luther Medical Products, Inc.
General Hospital · 85d
Cleared Jul 14, 1994
IPI DUAL LUMEN PORT
K934167
Pudenz-Schulte Medical Research Corp.
General Hospital · 321d
Cleared Jul 14, 1994
IPI LOW PROFILE IMPORT
K934796
Pudenz-Schulte Medical Research Corp.
General Hospital · 281d
Cleared Mar 22, 1994
THEREX LOW-PROFILE PORT
K934792
Therex Corp.
General Hospital · 167d
Cleared Mar 22, 1994
THEREX LOW-PROFILE PORT-TITANIUM
K934802
Therex Corp.
General Hospital · 166d
Cleared Mar 22, 1994
THEREX LOW PROFILE PORT-TITANIUM MODEL
K936012
Therex Corp.
General Hospital · 96d
Cleared Feb 25, 1994
PS MEDICAL IPI ACCESS KIT
K930206
Pudenz-Schulte Medical Research Corp.
General Hospital · 406d
Cleared Feb 25, 1994
CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS
K931748
Tri-State Hospital Supply Corp.
General Hospital · 323d
Cleared Feb 25, 1994
HMP POLYSULFONE PORT
K933986
Horizon Medical Products, Inc.
General Hospital · 192d