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
169–192 of 288
Cleared Nov 06, 1992
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT
K922434
Therex Corp.
General Hospital · 168d
Cleared Oct 16, 1992
A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM
K921475
Therex Corp.
General Hospital · 200d
Cleared Jul 21, 1992
VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST.
K921201
Med Institute, Inc.
General Hospital · 131d
Cleared Sep 18, 1991
PLASTIC ATTACHABLE DUAL PORT
K912702
Davol, Inc.
General Hospital · 91d
Cleared Aug 09, 1991
VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM
K913350
Med Institute, Inc.
General Hospital · 14d
Cleared Jul 30, 1991
VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112
K912423
Med Institute, Inc.
General Hospital · 60d
Cleared Jul 30, 1991
VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110
K912424
Med Institute, Inc.
General Hospital · 60d
Cleared Jul 30, 1991
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121
K912465
Med Institute, Inc.
General Hospital · 56d
Cleared Jun 24, 1991
VITAL-PORT VASCULAR ACCESS SYSTEM
K911449
Med Institute, Inc.
General Hospital · 96d
Cleared Apr 19, 1991
STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED
K905838
Strato Medical Corp.
Gastroenterology & Urology · 113d
Cleared Apr 19, 1991
STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED
K905839
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED
K905840
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED
K905841
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIED
K905842
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF
K905843
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED
K905845
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF
K905849
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED
K905850
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED
K905852
Strato Medical Corp.
General Hospital · 113d
Cleared Apr 19, 1991
A-PORT IMPLANT VASC ACCESS SYST LINE EXT-A2 PORT
K911055
Therex Corp.
General Hospital · 42d
Cleared Apr 15, 1991
LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015
K911355
Strato Medical Corp.
General Hospital · 53d
Cleared Apr 08, 1991
STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION
K905846
Strato Medical Corp.
General Hospital · 102d
Cleared Apr 08, 1991
LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI
K905848
Strato Medical Corp.
General Hospital · 102d
Cleared Apr 05, 1991
STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION
K905847
Strato Medical Corp.
General Hospital · 99d