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
49–72 of 288
Cleared Apr 17, 1996
CELSITE PEDIATRIC VENOUS SYSTEM
K952435
B.Braun Medical, Inc.
General Hospital · 329d
Cleared Mar 21, 1996
VASCULAR ACCESS PORT KIT
K955587
Boston Scientific Corp
General Hospital · 105d
Cleared Mar 21, 1996
A2 DETACHED DUAL PORT SYSTEM
K955819
Arrow Intl., Inc.
General Hospital · 86d
Cleared Dec 01, 1995
CELSITE VENOUS ACCESS SYSTEM OTW
K954297
B.Braun Medical, Inc.
General Hospital · 78d
Cleared Nov 15, 1995
VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K954433
Gish Biomedical, Inc.
General Hospital · 51d
Cleared Oct 02, 1995
VASPORT VASCULAR ACCESS PORT
K953571
Gish Biomedical, Inc.
General Hospital · 63d
Cleared Sep 19, 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
K953073
Arrow Intl., Inc.
General Hospital · 81d
Cleared Aug 10, 1995
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
K952748
United States Surgical, A Division of Tyco Healthc
General Hospital · 55d
Cleared Jul 21, 1995
CELSITE VENOUS SYSTEM
K952548
B.Braun Medical, Inc.
General Hospital · 49d
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 Jul 26, 1994
PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM
K942024
Pharmacia Deltec, Inc.
General Hospital · 91d
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 Feb 25, 1994
PS MEDICAL IPI ACCESS KIT
K930206
Pudenz-Schulte Medical Research Corp.
General Hospital · 406d
Cleared Jan 07, 1994
STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT
K932509
Strato Medical Corp.
General Hospital · 227d
Cleared Jan 05, 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S
K932095
Pharmacia Deltec, Inc.
General Hospital · 250d
Cleared Jan 05, 1994
PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM
K932840
Pharmacia Deltec, Inc.
General Hospital · 208d
Cleared Jan 05, 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS
K932841
Pharmacia Deltec, Inc.
General Hospital · 208d
Cleared Jul 07, 1993
LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555
K915273
Strato Medical Corp.
General Hospital · 590d
Cleared Jun 17, 1993
SNAP-LOCK MICROPORT - REVISED
K924505
Strato Medical Corp.
General Hospital · 286d
Cleared Apr 21, 1993
PHARMACIA DELTEC WINGED INFUSION SET
K923019
Pharmacia Deltec, Inc.
General Hospital · 302d
Cleared Nov 20, 1992
IPI IMPORT
K922419
Pudenz-Schulte Medical Research Corp.
General Hospital · 183d
Cleared Sep 18, 1991
PLASTIC ATTACHABLE DUAL PORT
K912702
Davol, Inc.
General Hospital · 91d