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
288 devices
73–96 of 288
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 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
Cleared Apr 05, 1991
STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED
K905851
Strato Medical Corp.
General Hospital · 99d
Cleared Apr 03, 1991
STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED
K905844
Strato Medical Corp.
General Hospital · 97d
Cleared Oct 10, 1990
PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
K903220
Pharmacia Deltec, Inc.
General Hospital · 79d
Cleared Mar 12, 1990
Q-PORT SYSTEM KIT
K894650
Quinton, Inc.
General Hospital · 231d
Cleared Dec 27, 1989
LIFEPORT VASCULAR ACCESS PORT
K895689
Strato Medical Corp.
General Hospital · 96d
Cleared Nov 17, 1989
LIFEPORT POLYURETHANE CATHETER
K895871
Strato Medical Corp.
General Hospital · 44d
Cleared Jun 03, 1988
LIFEPORT II, MODEL LPS-1100
K881075
Strato Medical Corp.
General Hospital · 81d
Cleared Apr 26, 1988
LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.
K880305
Strato Medical Corp.
General Hospital · 92d
Cleared Apr 13, 1988
PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM
K875276
Pharmacia Deltec, Inc.
General Hospital · 111d
Cleared Nov 03, 1987
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735
Medtronic Vascular
General Hospital · 49d