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
193–216 of 288
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 Mar 13, 1991
VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM
K910005
Med Institute, Inc.
General Hospital · 70d
Cleared Oct 17, 1990
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K904077
Med Institute, Inc.
General Hospital · 42d
Cleared Oct 12, 1990
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.
K903691
Therex Corp.
General Hospital · 58d
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 Dec 06, 1989
A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT
K896093
Therex Corp.
General Hospital · 48d
Cleared Nov 17, 1989
LIFEPORT POLYURETHANE CATHETER
K895871
Strato Medical Corp.
General Hospital · 44d
Cleared Jun 23, 1989
A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM
K893460
Therex Corp.
General Hospital · 51d
Cleared Jul 29, 1988
A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED
K882230
Therex Corp.
General Hospital · 63d
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 Feb 19, 1988
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
K875214
Therex Corp.
General Hospital · 63d
Cleared Dec 30, 1987
CHEMO-PORT
K874184
Hdc Corp.
General Hospital · 77d
Cleared Nov 03, 1987
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735
Medtronic Vascular
General Hospital · 49d
Cleared Oct 27, 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213
C.R. Bard, Inc.
General Hospital · 74d
Cleared Aug 25, 1987
NORFOLK NORPORT (TM) -SP (SKIN PARALLEL)
K872838
Norfolk Medical Products, Inc.
General Hospital · 36d
Cleared Jul 30, 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817
C.R. Bard, Inc.
General Hospital · 149d
Cleared Jun 24, 1987
NORFOLK MEDICAL NORPORT
K871209
Norfolk Medical Products, Inc.
General Hospital · 91d
Cleared Jun 10, 1987
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
K871192
Norfolk Medical Products, Inc.
General Hospital · 78d
Cleared May 07, 1987
NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT
K870187
Norfolk Medical Products, Inc.
General Hospital · 111d