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
49–72 of 288
Cleared Feb 02, 2006
GRANTALDER RHAPSODY ACCESS PORT AND CATHETER
K043178
Grantadler Corportation
General Hospital · 443d
Cleared Apr 18, 2005
BARDPORT TITANIUM PORTS
K050310
Bard Access Systems, Inc.
General Hospital · 69d
Cleared Feb 25, 2005
VORTEX EZ VASCULAR ACCESS PORT
K050176
Rita Medical Systems, Inc.
General Hospital · 30d
Cleared Jan 23, 2004
PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
K033686
Smiths Medical MD, Inc.
General Hospital · 60d
Cleared Jan 15, 2004
MODIFICATION TO X-PORT DUO PORT
K034065
C.R. Bard, Inc.
General Hospital · 17d
Cleared Nov 18, 2003
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
K033473
Horizon Medical Products, Inc.
General Hospital · 15d
Cleared Sep 12, 2003
VORTEX MP
K032754
Horizon Medical Products, Inc.
General Hospital · 7d
Cleared Sep 09, 2003
TRIUMPH VTX WITH LIFEVALVE CATHETER
K032557
Horizon Medical Products, Inc.
General Hospital · 21d
Cleared Sep 09, 2003
VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233
K032600
Boston Scientific Corp
General Hospital · 15d
Cleared Aug 19, 2003
VAXCEL PORT, MODELS 45-336 AND 45-338
K032375
Boston Scientific Corp
General Hospital · 18d
Cleared Aug 05, 2003
OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
K031282
LeMaitre Vascular, Inc.
General Hospital · 105d
Cleared Jul 15, 2003
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
K031844
Boston Scientific Corp
General Hospital · 29d
Cleared Jul 14, 2003
VAXCEL WITH PASV PORT, MODEL 45-213
K032008
Boston Scientific Corp
General Hospital · 14d
Cleared Jul 10, 2003
X-PROT DUO PORT
K032044
C.R. Bard, Inc.
General Hospital · 8d
Cleared Feb 12, 2003
OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05
K021580
LeMaitre Vascular, Inc.
General Hospital · 274d
Cleared Jan 28, 2003
VAXCEL WITH PASV PORT
K030083
Boston Scientific Corp
General Hospital · 19d
Cleared Sep 25, 2002
BARDPORT X-PORT ISP PORT
K022983
C.R. Bard, Inc.
General Hospital · 16d
Cleared Apr 10, 2001
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
K010767
Horizon Medical Products, Inc.
General Hospital · 27d
Cleared Mar 08, 2001
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
K010426
Sims Deltec, Inc.
General Hospital · 23d
Cleared Feb 12, 2001
VORTEX ACCESS SYSTEM
K010189
Horizon Medical Products, Inc.
General Hospital · 21d
Cleared Oct 27, 2000
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
K003006
Arrow Intl., Inc.
General Hospital · 31d
Cleared Sep 26, 2000
IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
K002770
Hdc Corp.
General Hospital · 20d
Cleared Mar 13, 2000
CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
K993024
B. Braun of America, Inc.
General Hospital · 186d
Cleared Feb 10, 2000
HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM
K994196
Horizon Medical Products, Inc.
General Hospital · 59d