LJS · Class II · 21 CFR 880.5970

FDA Product Code LJS: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

Under FDA product code LJS, long-term implanted intravascular therapeutic catheters are cleared for extended vascular access over weeks to months.

These tunneled or implanted central venous catheters provide durable, reliable access to the central venous circulation for long-term chemotherapy, parenteral nutrition, hemodialysis, and repeated blood sampling without repeated peripheral venipuncture.

LJS devices are Class II medical devices, regulated under 21 CFR 880.5970 and reviewed by the FDA General Hospital panel.

Leading manufacturers include C.R. Bard, Inc., Access Vascular, Inc. and Piccolo Medical, Inc..

302
Total
302
Cleared
131d
Avg days
1983
Since
302 devices
49–72 of 302
Cleared Oct 20, 2005
POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE
K051991
C.R. Bard, Inc.
General Hospital · 90d
Cleared Jun 30, 2005
6 FR FL POWERHOHN AND POWERLINE CATHETER
K051417
C.R. Bard, Inc.
General Hospital · 29d
Cleared Jun 15, 2005
6 FR DL POWERPICC CATHETER
K050931
C.R. Bard, Inc.
General Hospital · 62d
Cleared May 26, 2005
POWERHOHN AND POWERLINE CATHETERS
K050185
C.R. Bard, Inc.
General Hospital · 119d
Cleared Jan 14, 2005
6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
K043502
C.R. Bard, Inc.
General Hospital · 25d
Cleared Nov 01, 2004
TRIFUSION, MODEL 0609190/0659350
K041088
C.R. Bard, Inc.
General Hospital · 189d
Cleared Mar 19, 2004
POWERPICC CATHETERS, MODELS 3175155, 3175135
K033389
C.R. Bard, Inc.
General Hospital · 148d
Cleared Jan 21, 2004
POLY PER-Q-CATH PICC CATHETERS
K034019
C.R. Bard, Inc.
General Hospital · 28d
Cleared Jan 21, 2004
GROSHONG NXT PICC CATHETERS
K034020
C.R. Bard, Inc.
General Hospital · 28d
Cleared May 05, 2003
POLY PER-Q-CATH PICC CATHETERS
K031129
C.R. Bard, Inc.
General Hospital · 26d
Cleared Feb 07, 2003
SILICONE DUAL LUMEN RADPICC CATHETERS
K030255
C.R. Bard, Inc.
General Hospital · 14d
Cleared Dec 18, 2002
GROSHONG NXT DUAL LUMEN PICC CATHETERS
K023374
C.R. Bard, Inc.
General Hospital · 71d
Cleared Sep 10, 2001
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902
C.R. Bard, Inc.
General Hospital · 12d
Cleared Aug 01, 2001
CENTRAL VENOUS CATHETER
K003839
Boston Scientific Corp
General Hospital · 232d
Cleared Sep 19, 2000
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
K001901
C.R. Bard, Inc.
General Hospital · 89d
Cleared Jul 18, 1996
AUTO SUTURE CHEMOSITE TUNNELER
K961856
United States Surgical, A Division of Tyco Healthc
General Hospital · 65d
Cleared Nov 21, 1995
PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES
K954104
C.R. Bard, Inc.
General Hospital · 82d
Cleared Aug 10, 1989
DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE
K893126
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 107d
Cleared Aug 09, 1988
MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE
K882448
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 56d