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
25–48 of 288
Cleared Nov 14, 2007
TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
K072549
C.R. Bard, Inc.
General Hospital · 65d
Cleared Nov 01, 2007
TITANIUM POWERPORT ISP IMPLANTED PORT
K072215
C.R. Bard, Inc.
General Hospital · 84d
Cleared May 15, 2007
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
K070003
Medcomp
General Hospital · 132d
Cleared Jan 25, 2007
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
K063377
C.R. Bard, Inc.
General Hospital · 78d
Cleared Jul 31, 2006
CELSITE/ CELSITE CONCEPT, ACCESS PORTS
K061424
Aesculap, Inc.
General Hospital · 69d
Cleared Jul 14, 2006
POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE
K060812
C.R. Bard, Inc.
General Hospital · 112d
Cleared Jan 15, 2004
MODIFICATION TO X-PORT DUO PORT
K034065
C.R. Bard, Inc.
General Hospital · 17d
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 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 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 Oct 27, 2000
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
K003006
Arrow Intl., Inc.
General Hospital · 31d
Cleared Oct 20, 1998
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888
Boston Scientific Corp
General Hospital · 64d
Cleared Mar 10, 1997
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
K964538
Boston Scientific Corp
General Hospital · 118d
Cleared Mar 06, 1997
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
K964066
C.R. Bard, Inc.
General Hospital · 147d
Cleared Dec 16, 1996
CELSITE PORT WITH PRECONNECTED CATHETER
K962230
B.Braun Medical, Inc.
General Hospital · 189d
Cleared Oct 24, 1996
A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
K963684
Arrow Intl., Inc.
General Hospital · 73d
Cleared Jul 19, 1996
LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037
K961615
Arrow Intl., Inc.
General Hospital · 84d
Cleared Jul 19, 1996
LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
K961652
Arrow Intl., Inc.
General Hospital · 80d
Cleared Jul 18, 1996
A PORT DETACHED CATHETER SYSTEM CATALOG #1002
K961583
Arrow Intl., Inc.
General Hospital · 85d
Cleared Apr 26, 1996
THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER
K960572
Arrow Intl., Inc.
General Hospital · 79d